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idK153137_s0_e2000

K153137.txt

purpose for submission

Clearance of a new device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Purpose for submission:

idK153137_s0_e2000

K153137.txt

measurand

Anti-PF4/Heparin Total Antibodies

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Measurand:

idK153137_s0_e2000

K153137.txt

type of test

Automated, latex enhanced immuno-turbidimetric assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Type of test:

idK153137_s0_e2000

K153137.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Classification:

idK153137_s0_e2000

K153137.txt

panel

Hematology (81)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Panel:

idK153137_s0_e2000

K153137.txt

predicate device name

Asserachrom HPIA Test kit from Diagnostica Stago

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Predicate device name:

idK153137_s0_e2000

K153137.txt

applicant

Instrumentation Laboratory (IL) Co.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Applicant:

idK153137_s8000_e10000

K153137.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

: Bar code; manual entry 4. Specimen Sampling and Handling: Automated 5. Calibration: Automated, the calibrator is a component of the assay kit. 6. Quality Control: Two levels of control are recommended for a complete quality control program. HemosIL HIT-Ab(PF4-H) Controls Low and High are designed for this program. Each laboratory should establish its own mean and standard deviation, and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift, in accordance with good laboratory practice. Refer to the instrument’s Operator’s Manual for additional information. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK153137_s8000_e10000

K153137.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

imen Identification: Bar code; manual entry 4. Specimen Sampling and Handling: Automated 5. Calibration: Automated, the calibrator is a component of the assay kit. 6. Quality Control: Two levels of control are recommended for a complete quality control program. HemosIL HIT-Ab(PF4-H) Controls Low and High are designed for this program. Each laboratory should establish its own mean and standard deviation, and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift, in accordance with good laboratory practice. Refer to the instrument’s Operator’s Manual for additional information. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK150041_s0_e2000

K150041.txt

purpose for submission

Clearance of a new device

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Purpose for submission:

idK150041_s0_e2000

K150041.txt

measurand

Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Measurand:

idK150041_s0_e2000

K150041.txt

type of test

Whole blood hemostasis

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Type of test:

idK150041_s0_e2000

K150041.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Classification:

idK150041_s0_e2000

K150041.txt

panel

Hematology (81)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Panel:

idK150041_s0_e2000

K150041.txt

predicate device name

Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Predicate device name:

idK150041_s0_e2000

K150041.txt

applicant

Coramed Technologies, LLC

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Applicant:

idK150041_s8000_e10000

K150041.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

7 152 Functional Fibrinogen MA (mm) 15.2 31.9 151 FLEV (mg/dL) 278.2 580.6 152 N. Instrument Name CORA Instrument O. System Descriptions: 1. Modes of Operation: Automatic 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____x____ or No ________ 3. Specimen Identification: Manual patient identification entry 17 4. Specimen Sampling and Handling: Samples are collected in 3.2% sodium citrate. No further additives or preservatives are necessary to maintain the integrity of the sample, but samples must be used within two hours of draw to maintain in-use stability. The blood is applied to the sample port and is pulled into the four staging areas, mixed with dried reagents before transfer to the test cells. 5. Calibration: The CORA instrument is factory calibrated and does not require routine calibration. 6. Quality Control: Expected value Range for the Abnormal Wet Quality Control (WQC): Expected value ranges for the WQC material when used with CORA Multichannel Citrated cartridges were estimated, according to CLSI C28-A3c. Using three lots of WQC and three Multichannel Citrated cartridge lots, a total of over 135 test results were obtained. Reagent & Abnormal WQC (WQC) R (min) K (min) Angle (degrees) MA (mm) FLEV (mg/dl) CK - WQC 0.8–1.5 0.6–0.8 75–83 32–47 CRT – WQC 32–46 CKH – WQC 0.8–1.5 CFF – WQC 30–60 563–873 Citrated whole blood from a healthy individual should be tested in conjunction with the WQC. Laboratories should establish their own normal donor control for reagents and may consider the following: 1) Establish a normal donor control group for normal values using blood drawn from healthy adults, not exposed to medication affecting blood coagulation or platelet function. 2) If the results of donor control assays do not fall within the expected range, a second normal donor should be tested. If the second donor control assay results are also outside the expected range, the assay should be considered out of control and no further testing should be performed. Coramed recommends that, as a minimum, a normal donor control and the abnormal quality control material check be performed for each new lot of assay cartridges. Additional quality control checks on a monthly, weekly, daily or shift basis may be utilized based on the laboratory’s quality control policies. The end user should follow the recommendations of the applicable local and state regulatory guidelines and is advised to call technical support for assistance. 18 Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK150041_s8000_e10000

K150041.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

69.7 152 Functional Fibrinogen MA (mm) 15.2 31.9 151 FLEV (mg/dL) 278.2 580.6 152 N. Instrument Name CORA Instrument O. System Descriptions: 1. Modes of Operation: Automatic 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ____x____ or No ________ 3. Specimen Identification: Manual patient identification entry 17 4. Specimen Sampling and Handling: Samples are collected in 3.2% sodium citrate. No further additives or preservatives are necessary to maintain the integrity of the sample, but samples must be used within two hours of draw to maintain in-use stability. The blood is applied to the sample port and is pulled into the four staging areas, mixed with dried reagents before transfer to the test cells. 5. Calibration: The CORA instrument is factory calibrated and does not require routine calibration. 6. Quality Control: Expected value Range for the Abnormal Wet Quality Control (WQC): Expected value ranges for the WQC material when used with CORA Multichannel Citrated cartridges were estimated, according to CLSI C28-A3c. Using three lots of WQC and three Multichannel Citrated cartridge lots, a total of over 135 test results were obtained. Reagent & Abnormal WQC (WQC) R (min) K (min) Angle (degrees) MA (mm) FLEV (mg/dl) CK - WQC 0.8–1.5 0.6–0.8 75–83 32–47 CRT – WQC 32–46 CKH – WQC 0.8–1.5 CFF – WQC 30–60 563–873 Citrated whole blood from a healthy individual should be tested in conjunction with the WQC. Laboratories should establish their own normal donor control for reagents and may consider the following: 1) Establish a normal donor control group for normal values using blood drawn from healthy adults, not exposed to medication affecting blood coagulation or platelet function. 2) If the results of donor control assays do not fall within the expected range, a second normal donor should be tested. If the second donor control assay results are also outside the expected range, the assay should be considered out of control and no further testing should be performed. Coramed recommends that, as a minimum, a normal donor control and the abnormal quality control material check be performed for each new lot of assay cartridges. Additional quality control checks on a monthly, weekly, daily or shift basis may be utilized based on the laboratory’s quality control policies. The end user should follow the recommendations of the applicable local and state regulatory guidelines and is advised to call technical support for assistance. 18 Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK143329_s0_e2000

K143329.txt

purpose for submission

To obtain clearance for a new device, Amplivue® Trichomonas Assay

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Purpose for submission:

idK143329_s0_e2000

K143329.txt

measurand

A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Measurand:

idK143329_s0_e2000

K143329.txt

type of test

Nucleic acid amplification assay (Helicase-dependent Amplification, HDA)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Type of test:

idK143329_s0_e2000

K143329.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Classification:

idK143329_s0_e2000

K143329.txt

product code

OUY - Trichomonas vaginalis nucleic acid amplification test system

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Product code:

idK143329_s0_e2000

K143329.txt

panel

83 - Microbiology

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Panel:

idK143329_s0_e2000

K143329.txt

intended use

The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Intended use:

idK143329_s0_e2000

K143329.txt

predicate device name

APTIMA Trichomonas vaginalis Assay (PANTHER® System)

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Predicate device name:

idK143329_s0_e2000

K143329.txt

applicant

Quidel Corporation

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Applicant:

idK143329_s0_e2000

K143329.txt

proprietary and established names

Amplivue® Trichomonas Assay

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Proprietary and established names:

idK143329_s0_e2000

K143329.txt

regulation section

21 CFR 866.3860

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Regulation section:

idK143329_s6000_e8000

K143329.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

.2) 100 (99.3 to 100) Symptomatic 342 59 6 277 0 17.3 100 (93.9 to 100) 97.9 (95.5 to 99.0) 90.8 (81.3 to 95.7) 100 (98.6 to 100) All 989 120 16* 853 0 12.1 100 (96.9 to 100) 98.2 (97.0 to 98.9) 88.2 (81.7 to 92.6) 100 (99.6 to 100) 14 Performance Characteristics of the AmpliVue® Trichomonas Assay by Symptom Status compared to the Composite Reference Method Site Number Symptom Status N TP FP TN FN Prev% Sensitivity% (95% CI) Specificity% (95% CI) PPV % (95% CI) NPV % (95% CI) Site 1 Asymptomatic 133 26 3 104 0 19.5 100 (87.1 to 100) 97.2 (92.1 to 99.0) 89.7 (73.6 to 96.4) 100 (96.4 to 100) Symptomatic 163 27 2 134 0 16.6 100 (87.5 to 100) 98.5 (94.8 to 99.6) 93.1 (78.0 to 98.1) 100 (97.2 to 100) All 296 53 5 238 0 17.9 100 (93.2 to 100) 97.9 (95.3 to 99.1) 91.4 (81.4 to 96.3) 100 (98.4 to 100) Site 2 Asymptomatic 46 5 1 40 0 10.9 100 (56.6 to 100) 97.6 (87.4 to 99.6) 83.3 (43.6 to 97.0) 100 (91.2 to 100) Symptomatic 69 17 1 51 0 24.6 100 (81.6 to 100) 98.1 (89.9 to 99.7) 94.4 (74.2 to 99.0) 100 (93.0 to 100) All 115 22 2 91 0 19.1 100 (85.1 to 100) 97.8 (92.5 to 99.4) 91.7 (74.2 to 97.7) 100 (95.9 to 100) Site 3 Asymptomatic 206 20 3 183 0 9.7 100 (83.9 to 100) 98.4 (95.4 to 99.4) 87.0 (67.9 to 95.5) 100 (97.9 to 100) Symptomatic 41 7 2 32 0 17.1 100 (64.6 to 100) 94.1 (80.9 to 98.4) 77.8 (45.3 to 93.7) 100 (89.3 to 100) All 247 27 5 215 0 10.9 100 (87.5 to 100) 97.7 (94.8 to 99.0) 84.4 (68.2 to 93.1) 100 (98.2 to 100) Site 4 Asymptomatic 260 10 3 247 0 3.8 100 (72.2 to 100) 98.8 (96.5 to 99.6) 76.9 (49.7 to 91.8) 100 (98.5 to 100) Symptomatic 35 3 1 31 0 8.6 100 (43.8 to 100) 96.9 (84.3 to 99.4) 75.0 (30.1 to 95.4) 100 (89.0 to 100) All 295 13 4 278 0 4.4 100 (77.2 to 100) 98.6 (96.4 to 99.4) 76.5 (52.7 to 90.4) 100 (98.6 to 100) Site 5 Asymptomatic 2 0 0 2 0 0 N/A 100 (34.2 to 100) N/A 100 (34.2 to 100) Symptomatic 34 5 0 29 0 14.7 100 (56.6 to 100) 100 (88.3 to 100) 100 (56.6 to 100) 100 (88.3 to 100) All 37 5 0 31 0 13.5 100 (56.6 to 100) 100 (89.0 to 100) 100 (56.6 to 100) 100 (89.0 to 100) * Eight (8) of sixteen (16) Composite reference negative/AmpliVue positive specimens were positive by a FDA- cleared Trichomonas vaginalis molecular device. 15 b. Clinical specificity: See section M 3a. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The prevalence of T. vaginalis (by asymptomatic, symptomatic status, and combined) detected by the AmpliVue® Trichomonas Assay in the multi-center study was calculated and is provided in the table below. Symptom Status All Sites Combined Site 1 Site 2 Site 3 Site 4 Site 5 Asymptomatic 11.0% 21.8% 12.8% 11.2% 5.0% 0.0% Symptomatic 19.0% 17.8% 26.1% 22.0% 11.4% 14.7% Combined 13.7% 19.6% 20.7% 13.0% 5.8% 13.5% N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK143329_s6000_e8000

K143329.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

to 92.2) 100 (99.3 to 100) Symptomatic 342 59 6 277 0 17.3 100 (93.9 to 100) 97.9 (95.5 to 99.0) 90.8 (81.3 to 95.7) 100 (98.6 to 100) All 989 120 16* 853 0 12.1 100 (96.9 to 100) 98.2 (97.0 to 98.9) 88.2 (81.7 to 92.6) 100 (99.6 to 100) 14 Performance Characteristics of the AmpliVue® Trichomonas Assay by Symptom Status compared to the Composite Reference Method Site Number Symptom Status N TP FP TN FN Prev% Sensitivity% (95% CI) Specificity% (95% CI) PPV % (95% CI) NPV % (95% CI) Site 1 Asymptomatic 133 26 3 104 0 19.5 100 (87.1 to 100) 97.2 (92.1 to 99.0) 89.7 (73.6 to 96.4) 100 (96.4 to 100) Symptomatic 163 27 2 134 0 16.6 100 (87.5 to 100) 98.5 (94.8 to 99.6) 93.1 (78.0 to 98.1) 100 (97.2 to 100) All 296 53 5 238 0 17.9 100 (93.2 to 100) 97.9 (95.3 to 99.1) 91.4 (81.4 to 96.3) 100 (98.4 to 100) Site 2 Asymptomatic 46 5 1 40 0 10.9 100 (56.6 to 100) 97.6 (87.4 to 99.6) 83.3 (43.6 to 97.0) 100 (91.2 to 100) Symptomatic 69 17 1 51 0 24.6 100 (81.6 to 100) 98.1 (89.9 to 99.7) 94.4 (74.2 to 99.0) 100 (93.0 to 100) All 115 22 2 91 0 19.1 100 (85.1 to 100) 97.8 (92.5 to 99.4) 91.7 (74.2 to 97.7) 100 (95.9 to 100) Site 3 Asymptomatic 206 20 3 183 0 9.7 100 (83.9 to 100) 98.4 (95.4 to 99.4) 87.0 (67.9 to 95.5) 100 (97.9 to 100) Symptomatic 41 7 2 32 0 17.1 100 (64.6 to 100) 94.1 (80.9 to 98.4) 77.8 (45.3 to 93.7) 100 (89.3 to 100) All 247 27 5 215 0 10.9 100 (87.5 to 100) 97.7 (94.8 to 99.0) 84.4 (68.2 to 93.1) 100 (98.2 to 100) Site 4 Asymptomatic 260 10 3 247 0 3.8 100 (72.2 to 100) 98.8 (96.5 to 99.6) 76.9 (49.7 to 91.8) 100 (98.5 to 100) Symptomatic 35 3 1 31 0 8.6 100 (43.8 to 100) 96.9 (84.3 to 99.4) 75.0 (30.1 to 95.4) 100 (89.0 to 100) All 295 13 4 278 0 4.4 100 (77.2 to 100) 98.6 (96.4 to 99.4) 76.5 (52.7 to 90.4) 100 (98.6 to 100) Site 5 Asymptomatic 2 0 0 2 0 0 N/A 100 (34.2 to 100) N/A 100 (34.2 to 100) Symptomatic 34 5 0 29 0 14.7 100 (56.6 to 100) 100 (88.3 to 100) 100 (56.6 to 100) 100 (88.3 to 100) All 37 5 0 31 0 13.5 100 (56.6 to 100) 100 (89.0 to 100) 100 (56.6 to 100) 100 (89.0 to 100) * Eight (8) of sixteen (16) Composite reference negative/AmpliVue positive specimens were positive by a FDA- cleared Trichomonas vaginalis molecular device. 15 b. Clinical specificity: See section M 3a. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: The prevalence of T. vaginalis (by asymptomatic, symptomatic status, and combined) detected by the AmpliVue® Trichomonas Assay in the multi-center study was calculated and is provided in the table below. Symptom Status All Sites Combined Site 1 Site 2 Site 3 Site 4 Site 5 Asymptomatic 11.0% 21.8% 12.8% 11.2% 5.0% 0.0% Symptomatic 19.0% 17.8% 26.1% 22.0% 11.4% 14.7% Combined 13.7% 19.6% 20.7% 13.0% 5.8% 13.5% N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK181525_s0_e2000

K181525.txt

purpose for submission

New Device

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Purpose for submission:

idK181525_s0_e2000

K181525.txt

measurand

Free Protein S Antigen (%)

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Measurand:

idK181525_s0_e2000

K181525.txt

type of test

Quantitative immunoturbidimetric assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Type of test:

idK181525_s0_e2000

K181525.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Classification:

idK181525_s0_e2000

K181525.txt

product code

GGP, Test, qualitative and quanititative factor deficiency

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Product code:

idK181525_s0_e2000

K181525.txt

panel

Hematology (81)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Panel:

idK181525_s0_e2000

K181525.txt

intended use

For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Intended use:

idK181525_s0_e2000

K181525.txt

predicate device name

STA-Liatest Free Protein S

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Predicate device name:

idK181525_s0_e2000

K181525.txt

applicant

Siemens Healthcare Diagnostics Product GmbH

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Applicant:

idK181525_s0_e2000

K181525.txt

proprietary and established names

INNOVANCE® Free PS Ag

IAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Proprietary and established names:

idK181525_s0_e2000

K181525.txt

regulation section

21 CFR 864.7290, Factor deficiency test

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K181525 B. Purpose for Submission: New Device C. Measurand: Free Protein S Antigen (%) D. Type of Test: Quantitative immunoturbidimetric assay E. Applicant: Siemens Healthcare Diagnostics Product GmbH F. Proprietary and Established Names: INNOVANCE® Free PS Ag G. Regulatory Information: 1. Regulation section: 21 CFR 864.7290, Factor deficiency test 2. Classification: Class II 3. Product code: GGP, Test, qualitative and quanititative factor deficiency 4. Panel: Hematology (81) 2 H. Intended Use: 1. Intended use(s): For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS- 5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex® Automated Blood Coagulation Analyzer CS-5100 I. Device Description: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components— INNOVANCE Free PS Ag Reagent and INNOVANCE Free PS Ag Buffer. The reagent contains polystyrene particles coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The buffer is a saline solution which contains a heterophilic blocking reagent to minimize interference from heterophile antibodies (e.g. human anti-mouse antibodies (HAMA) or rheumatoid factors). J. Substantial Equivalence Information: 1. Predicate device name(s): STA-Liatest Free Protein S 2. Predicate 510(k) number(s): K010963 3. Comparison with predicate: 3 Similarities Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Intended use For the quantitative determination of free protein S in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex CS‑5100 analyzer. As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations. The STA-Liatest Free Protein S kit is intended for use on various models of the STA analyzers for the quantitative determination of the free PS level in citrated plasma by the immuno-turbimetric method. Test principle Immunoturbidimetry Same Sample type Human plasma, 3.2% sodium citrate Same Measuring range 10–150% of norm Same Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S Buffer Buffered saline solution containing heterophilic blocking reagent for minimizing interferences by heterophilic antibodies and rheumatoid factors. HEPES buffer Shelf-life stability 12 months at 2–8 °C 18 months at 2–8 °C On-board stability 96 hours 32 hours (in original vial) 5 days (with STA-mini reducer and the perforated cap) 4 Differences Item Device INNOVANCE Free PS Ag Predicate STA-Liatest Free Protein S High dose hook effect The INNOVANCE Free PS Ag assay on the Sysmex CS-5100 system shows no high dose hook effect up to 588% of norm. No dose-hook effect has been observed with free protein S levels up to 200%. K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI EP28-A3,Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline-Third Edition. CLSI H21-A5, Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline-Fifth Edition. CLSI I/LA30-A , Immunoassay Interference by Endogenous Antibodies; Approved Guideline. L. Test Principle: The INNOVANCE Free PS Ag assay is an immunoturbidimetric assay consisting of a reagent and buffer. The reagent contains polystyrene (latex) particles covalently coated with two different monoclonal mouse antibodies (mAb A and mAb B) specific for free protein S. The latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected at 800 nm via an increase in turbidity. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: To obtain measures of repeatability and reproducibility imprecision for the INNOVANCE Free PS Ag Assay, commercial qualitity controls (normal and pathological) and human plasma pools with concentrations in the lower and upper ranges as well as around the medical decision levels (MDLs), were analyzed on the Sysmex CS-5100 analyzer. i. Single-site Studies To assess lot variability, three lots of the INNOVANCE Free PS Ag reagent were tested on one Sysmex CS-5100 analyzer. For each lot of reagent, a sample set consisting of five samples (two levels of commercial quality control and three human plasma pools–low, MDL, high) were evaluated. The sample set was tested on 20 non-consecutive days in duplicate with two runs per day, for a total of 240 replicates per sample (80 replicates per sample per lot). Within-run, between-run, between-lot, between-day, and total imprecision were calculated and met the predefined acceptance criteria. In addition to the study described aboved, a single-site study was conducted internally with one INNOVANCE Free PS Ag lot tested on three Sysmex CS- 5100 instruments (one operator per instrument). The same set of five samples as described above were evaluated. Each sample was tested on five days, with two runs per day and four replicates per run, for a total of 120 replicates per sample. Within-run, between-run, between-day, between-instrument and total imprecision were calculated. All results met the predefined acceptance criteria. Sample Mean (% of norm) Between-Lot Within-Run Between- Run Between- Day Total SD %CV SD %CV SD %CV SD %CV SD %CV Low 14.7 0.13 0.88 0.38 2.63 0.00 0.00 0.07 0.5 0.41 2.82 CPP 28.29 0.21 0.74 0.34 1.19 0.12 0.42 0.09 0.3 0.42 1.49 MDL 61.31 0.61 1.0 0.33 0.54 0.36 0.58 0.25 0.41 % 0.82 1.34 CPN 86.36 0.18 1.36 0.49 0.57 1.27 1.47 0.00 0.0 1.80 2.09 High 139.33 0.86 0.62 0.75 0.54 0.66 0.47 0.64 0.46 % 1.46 1.05 6 ii. Multi-site Study A multi-site study using the same set of five samples as described above was performed on one Sysmex CS-5100 analyzer at three sites using one lot of INNOVANCE Free PS Ag. Each sample set was tested in two replicates per run with two runs per day for 20 non-consecutive days, for a total of N=240 replicates for each level tested. Within-run, between-run, between-day, between- site, and total precision were calculated and met the predefined acceptance criteria. b. Linearity/assay reportable range: Linearity studies were performed on one Sysmex CS-5100 analyzer with three lots of reagent over a period of three days. Each sample was tested in quadruplicate for each lot, with one run per day. Eleven different dilutions were prepared using a plasma pool to cover the linear range (10–150% norm). The high pool was prepared Regulation section:

idK181525_s6000_e8000

K181525.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 809.10.

free protein S concentration (Low, Medical Decision Level (MDL) and High) and tested on three different INNOVANCE Free PS Ag lots. The study demonstrated no cross-reactivity with protein S bound to C4b-binding protein (C4BP) was observed. The results of the study demonstrated that addition of C4BP to a plasma sample, leads to an increase of protein S bound to C4BP and a decrease of free protein S, which reduces the test results of INNOVANCE Free PS Ag in a concentration-dependent manner. High Dose Hook: To evaluate a hook (prozone) effect, fresh normal plasma was used and spiked with purified human protein S to prepare 10 different dilution samples and tested on three Free PS Ag reagent lots. The study demonstrated that no hook effect was observed up to a concentration of 588% of norm free protein S. Free protein S concentrations above the measuring interval of the assay were flagged by the analyzer. Carryover: 14 Sample Carryover: The sample carryover study was evaluated to determine the level of contamination from high-analyte test samples into low-analyte test samples. The study was performed on one Sysmex CS-5100, using one reagent lot. A total of 21 measurements, using fresh pooled normal plasma were evaluated. The relative mean deviation was calculated at -0.4% and found to be within the predefined acceptance criteria. Reagent Carryover: The reagent carryover study was conducted using three different samples: a normal sample, a sample near the medical decision point and a pathological sample. Each sample was tested with both an acceptor application (Free PS Ag Reagent) and a donor application (reagents that are representative of different methodologies: clotting, chromogenic, immunologic) on specific pipettors of the Sysmex CS-5100 analyzer. The mean values were calculated for each sample and the relative mean (percent) were calculated for each application and found to be within predefined acceptance criteria. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Reference interval studies were conducted at three clinical sites in the U.S. at different geographic locations to reflect the U.S. population. Citrated plasma samples were obtained from 300 apparently healthy individuals (149 males and 151 females) ≥ 18 years with no current or recent history of a bleeding disorder or unexpected extended bleeding episodes. Results from all sites were pooled and all reference intervals were established by calculating the non-parametric 95% confidence interval (2.5th to 97.5th percentiles). The calculated normal reference range for INNOVANCE Free PS Ag assay is 72.8–138.8% for males and 65.8–146.7% for females. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK181525_s6000_e8000

K181525.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

for each free protein S concentration (Low, Medical Decision Level (MDL) and High) and tested on three different INNOVANCE Free PS Ag lots. The study demonstrated no cross-reactivity with protein S bound to C4b-binding protein (C4BP) was observed. The results of the study demonstrated that addition of C4BP to a plasma sample, leads to an increase of protein S bound to C4BP and a decrease of free protein S, which reduces the test results of INNOVANCE Free PS Ag in a concentration-dependent manner. High Dose Hook: To evaluate a hook (prozone) effect, fresh normal plasma was used and spiked with purified human protein S to prepare 10 different dilution samples and tested on three Free PS Ag reagent lots. The study demonstrated that no hook effect was observed up to a concentration of 588% of norm free protein S. Free protein S concentrations above the measuring interval of the assay were flagged by the analyzer. Carryover: 14 Sample Carryover: The sample carryover study was evaluated to determine the level of contamination from high-analyte test samples into low-analyte test samples. The study was performed on one Sysmex CS-5100, using one reagent lot. A total of 21 measurements, using fresh pooled normal plasma were evaluated. The relative mean deviation was calculated at -0.4% and found to be within the predefined acceptance criteria. Reagent Carryover: The reagent carryover study was conducted using three different samples: a normal sample, a sample near the medical decision point and a pathological sample. Each sample was tested with both an acceptor application (Free PS Ag Reagent) and a donor application (reagents that are representative of different methodologies: clotting, chromogenic, immunologic) on specific pipettors of the Sysmex CS-5100 analyzer. The mean values were calculated for each sample and the relative mean (percent) were calculated for each application and found to be within predefined acceptance criteria. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Reference interval studies were conducted at three clinical sites in the U.S. at different geographic locations to reflect the U.S. population. Citrated plasma samples were obtained from 300 apparently healthy individuals (149 males and 151 females) ≥ 18 years with no current or recent history of a bleeding disorder or unexpected extended bleeding episodes. Results from all sites were pooled and all reference intervals were established by calculating the non-parametric 95% confidence interval (2.5th to 97.5th percentiles). The calculated normal reference range for INNOVANCE Free PS Ag assay is 72.8–138.8% for males and 65.8–146.7% for females. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK170464_s0_e2000

K170464.txt

measurand

Fresh capillary whole blood glucose from the fingertip

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Measurand:

idK170464_s0_e2000

K170464.txt

type of test

Quantitative, amperometric assay (Glucose Oxidase)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Type of test:

idK170464_s0_e2000

K170464.txt

classification

Class II

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Classification:

idK170464_s0_e2000

K170464.txt

product code

NBW, System, Test, Blood Glucose, Over The Counter

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Product code:

idK170464_s0_e2000

K170464.txt

panel

Clinical Chemistry (75)

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Panel:

idK170464_s0_e2000

K170464.txt

intended use

See indication(s) for use below.

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Intended use:

idK170464_s0_e2000

K170464.txt

predicate device name

StatStrip Xpress Blood Glucose Monitoring System

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Predicate device name:

idK170464_s0_e2000

K170464.txt

applicant

Nova Biomedical Corporation

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Applicant:

idK170464_s0_e2000

K170464.txt

proprietary and established names

StatStrip Xpress Blood Glucose Monitoring System

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Proprietary and established names:

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K170464.txt

regulation section

21 CFR 862.1345, Glucose test system

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k170464 B. Purpose for Submission: This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). Accuracy information has been added to the outer carton labeling, and the presentation format of accuracy information on the test strip package insert has been modified. C. Measurand: Fresh capillary whole blood glucose from the fingertip D. Type of Test: Quantitative, amperometric assay (Glucose Oxidase) E. Applicant: Nova Biomedical Corporation F. Proprietary and Established Names: StatStrip Xpress Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter 2 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See indication(s) for use below. 2. Indication(s) for use: The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use with neonates. The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor and StatStrip Xpress Glucose Test Strips. The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). 3. Special conditions for use statement(s): • For over-the-counter use • For single-patient use only. • Critically ill patients should not be tested with this device. • Inaccurate results may occur in severely hypotensive individuals or patients in shock. • Inaccurate low results may occur for individuals experiencing a hyperglycemic- hyperosmolar state, with or without ketosis. • Incorrect result may occur in individuals who are dehydrated. • The system should not be used to test neonates. • Do not reuse; each Test Strip is for single use only. • Do not test samples other than fresh capillary whole blood obtained from the fingertip. • Do not use at altitudes above 15,000 feet (4572 meters) above sea level. • Do not use when humidity is higher than 90% and lower than 10%, as extremes in humidity may affect results. • Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 20% to 65%. • Not intended for the diagnosis or screening of diabetes. • This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as 3 part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodblorne pathogens. 4. Special instrument requirements: StatStrip Xpress Blood Glucose Monitor I. Device Description: The modified StatStrip Xpress Blood Glucose Monitoring System, which includes StatStrip Xpress Blood Glucose Monitor, StatStrip Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions (Levels 1, 2, and 3, sold separately), is identical to the device cleared in k160156. Only labeling changes have been made to the outer box labeling and test strips package insert. J. Substantial Equivalence Information: 1. Predicate device name(s): StatStrip Xpress Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k160156 3. Comparison with predicate: Similarities Item Candidate Device Predicate Device (k160156) Intended Use/Indications for Use Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. Same Specimen type Fresh capillary whole blood from fingertip Same Test Principle Electrochemical biosensor, amperometric Same Enzyme Glucose Oxidase Same 4 Differences Item Candidate Device Predicate Device (k160156) Outer carton labeling System accuracy data and interference information included on the outer carton labeling System accuracy data and interference information not included on the outer carton labeling Test strip package insert System accuracy data represented in one table for all glucose concentrations where data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins. System accuracy data represented in two tables for glucose concentrations < 75 mg/dL and > 75 mg/dL where data is separated into ‘within 5mg/dL’, ‘within 10 mg/dL’, and ‘within 15 mg/dL’ bins for glucose concentrations < 75 mg/dL and data is separated into ‘within 5%’, ‘within 10%’, ‘within 15%’, and ‘within 20%’ bins for glucose concentrations > 75 mg/dL. K. Standard/Guidance Document Referenced (if applicable): No applicable standard was cited. L. Test Principle: The StatStrip Xpress Blood Glucose Monitoring System measures glucose levels using disposable test strips and a handheld meter. The test strip contains a flow channel to draw blood by capillary action into a biosensor measurement zone. The sensor comprises an enzyme (Glucose oxidase) that oxidizes glucose present in the blood sample. The sensor also contains an electron shuttle to re-generate, by oxidation, the active form of the enzyme. The meter applies a low electrical voltage to the sensor electrodes and measures a change in current caused by the electrochemical oxidation of the electron shuttle. M. Performance Characteristics (if/when applicable): This submission seeks changes in labeling for the previously cleared StatStrip Xpress Blood Glucose Monitoring System (k160156). The technological characteristics of the modified device are identical to the technological characteristics of the cleared device (k160156). The StatStrip Xpress Blood Glucose Monitoring System cleared in k160156 uses identical technology to the StatStrip Glucose Hospital Meter System (originally cleared in k060345 and modified in k063821, k070960, k132121, and k150461). Performance of the modified device was established using these previously cleared devices, which are cited (as 5 appropriate) in each section. 1. Analytical performance: a. Precision/Reproducibility: Within-run and intermediate precision were established in k060345. b. Linearity/assay reportable range: Linearity and reportable range were established in k060345. The reportable range for the StatStrip Xpress Blood Glucose Monitoring System is 20 to 600 mg/dL. Readings outside of reportable range Bench studies and software verification studies were provided to demonstrate that if a glucose measurement is less than 20 mg/dL, the result is flagged and a ‘LO’ indicator is displayed. If a glucose measurement exceeds 600 mg/dL, the result is flagged and a ‘HI’ indicator is displayed. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability The StatStrip Xpress Blood Glucose Monitoring System is traceable to NIST Standard SRM917B. Test Strip Stability Stability protocols and acceptance criteria for the StatStrip Xpress Blood Glucose Test Strips were evaluated in k060345 and found to be acceptable. The claimed closed-vial stability is 24 months at 34-86°F and 10-90% RH. The claimed open-vial stability is 6 months when stored at the recommended storage temperatures 34-86°F and 10-90% RH or until the expiration date printed on the label, whichever comes first. d. Detection limit: See the linearity study in Section M.1.b. above. e. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k132121. The following information has been added to the outer carton labeling: “Eliminates interferences from common medicines such as Ibuprofen, Acetaminophen, and Vitamin C.” 6 f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Method comparison studies were established in k060345. b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Accuracy in the hands of the intended users was established in k160156 Regulation section:

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K170464.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

to conducting a human factors study to assess intended user understanding of accuracy labeling, the sponsor assessed ways to display device accuracy information on the outer box labeling of the device for easy understanding by the intended user. Twenty design concepts for accuracy labeling were created and assessed internally by the sponsor as well as through studies with external lay people with diabetes (who did not participate in the human factors study) to identify the most simple and easy to understand the information presented. These designs included varied displays such as text only, pie charts, bar charts, line graphs, and bulls eye graphs with and without text. Independent diabetes educator professionals were also consulted on the design and presentation of labeling. The results of this accuracy labeling design assessment supported the bulls eye graphic presented as part of this effort as easiest for lay users to understand. A human factors study was then performed using the accuracy labeling design selected in the initial accuracy design phase assessment. For the human factors study, 100 male and female intended use subjects across ethnicities (African American, 7 Caucasian, Native American) and ages (25 to 83 years), and having not received higher levels of formal education (at least 75% of subjects completed 12 years or fewer of high school education; no more than 25% of subjects attended college or higher education) participated in the human factors study. Subjects were included in the study if they were 18 years of age or older, able to read and write English, diagnosed with Type 1 or Type 2 Diabetes, and met the educational requirements above. Subjects with a cognitive disorders or other similar conditions were excluded. As part of the study, each subject completed a mathematics understanding assessment (MUA) in order to determine a subject’s understanding of basic mathematics concepts. The MUA established the baseline numeracy skills (e.g., comparisons of two numbers, understanding of percentages) of the subjects since the human factors assessment of accuracy labeling comprehension incorporated basic mathematics concepts (e.g., comparisons of pairs of accuracy values). The average score for 100 subjects for the MUA was 71.3%. As part of the assessment of accuracy labeling comprehension, each subject completed assessments for the front panel (1A) and side panel (1B) of the proposed outer carton labeling (System A) and comparisons of labeling for System A to System B (2), System C (3), and System D (4) to determine a subject’s overall understanding of meter accuracy information. For assessment 1A and 1B, subjects were asked multiple choice questions about the front and side panels of the proposed labeling (System A). The front and side panels of the proposed labeling and the results of these assessments are shown below. 8 System A (proposed labeling) Front panel: Side panel: Assessment 1A: Front panel of proposed labeling Question Average score for 100 subjects (%) What is the Accuracy [within 10% of lab results] for this meter? 92 Is the Accuracy of 95 better than an Accuracy of 78? 91 An Accuracy of 95 is equal to which of the following? 97 9 Assessment 1B: Side panel of proposed labeling Question Average score for 100 subjects (%) Out of 100 tests performed, how many glucose results are within 15% of a glucose test performed in a hospital lab? 76 True or False: 78 out of 100 tests performed on this meter are within 5% of glucose testing performed in a hospital lab? 88 Out of 100 tests performed, how many glucose results are within 10% of a glucose test performed within a hospital lab? 89 According to this table, 95 out of 100 tests are within 10% of lab results. Are the other 5 tests within 10% of lab results? 52 This labeling information compares the accuracy of this glucose meter to which of the following? (Select one) 91 For assessments 2, 3, and 4, subjects were asked to compare the proposed labeling for System A to Systems B, C, or D. The side panels for Systems B, C, and D and the results of these assessments are shown below. The front panels for Systems B, C, and D (not shown) display the accuracy values within 10% of lab results (i.e., 81 out of 100 tests for System B, 89 out of 100 tests for System C, and 91 out of 100 tests for System D). System B: System C: System D: 10 Assessments 2, 3, 4: Comparison of System A to Systems B, C, or D Average score for 100 subjects (%) Question (2) System A vs. System B (3) System A vs. System C (4) System A vs. System D Which meter has a [higher or lower] Accuracy [within 10% of lab results]? If unsure, please explain. 98 97 98 When comparing the two meters for results that are within 5% of lab results, which meter is more accurate? If unsure, please explain. 91 96 89 When comparing the two meters for results that are within 10% of lab results, which meter is [less or more] accurate? If unsure, please explain. 87 93 89 When comparing the two meters for results that are within 15% of lab results, which meter is [less or more] accurate? If unsure, please explain. 71 84 96 Overall, which meter is [less or more] accurate? If unsure, please explain. 89 90 94 (Check True or False) For System A, there are more results that fall within 10% of Lab Results than results that fall within 5% of lab results? 91 93 93 (Check True or False) For System [B or C or D], there are more results that fall within 5% of Lab Results than results that fall within 10% of lab results? 75 84 83 The results for assessments 1A, 1B, 2, 3, and 4 shown above support the intended user understanding of the proposed outer carton accuracy labeling. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: The StatStrip Xpress Blood Glucose Test Strips package insert includes the following: The normal fasting adult blood Glucose range for a person without diabetes is less than 100 mg/dL. One to two hours after meals, normal blood Glucose levels should be less than 140 mg/dL. 11 From: American Diabetes Association, Standards of Medical Care in Diabetes. Diabetes Care, Vol 40, Supplement 1. January 2017. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Refer to the decision memorandum for k160156 for information related to hematocrit range, altitude, temperature and humidity, sample volume, infection control, electromagnetic compatibility, readability evaluation, and customer service. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

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K170464.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

study Prior to conducting a human factors study to assess intended user understanding of accuracy labeling, the sponsor assessed ways to display device accuracy information on the outer box labeling of the device for easy understanding by the intended user. Twenty design concepts for accuracy labeling were created and assessed internally by the sponsor as well as through studies with external lay people with diabetes (who did not participate in the human factors study) to identify the most simple and easy to understand the information presented. These designs included varied displays such as text only, pie charts, bar charts, line graphs, and bulls eye graphs with and without text. Independent diabetes educator professionals were also consulted on the design and presentation of labeling. The results of this accuracy labeling design assessment supported the bulls eye graphic presented as part of this effort as easiest for lay users to understand. A human factors study was then performed using the accuracy labeling design selected in the initial accuracy design phase assessment. For the human factors study, 100 male and female intended use subjects across ethnicities (African American, 7 Caucasian, Native American) and ages (25 to 83 years), and having not received higher levels of formal education (at least 75% of subjects completed 12 years or fewer of high school education; no more than 25% of subjects attended college or higher education) participated in the human factors study. Subjects were included in the study if they were 18 years of age or older, able to read and write English, diagnosed with Type 1 or Type 2 Diabetes, and met the educational requirements above. Subjects with a cognitive disorders or other similar conditions were excluded. As part of the study, each subject completed a mathematics understanding assessment (MUA) in order to determine a subject’s understanding of basic mathematics concepts. The MUA established the baseline numeracy skills (e.g., comparisons of two numbers, understanding of percentages) of the subjects since the human factors assessment of accuracy labeling comprehension incorporated basic mathematics concepts (e.g., comparisons of pairs of accuracy values). The average score for 100 subjects for the MUA was 71.3%. As part of the assessment of accuracy labeling comprehension, each subject completed assessments for the front panel (1A) and side panel (1B) of the proposed outer carton labeling (System A) and comparisons of labeling for System A to System B (2), System C (3), and System D (4) to determine a subject’s overall understanding of meter accuracy information. For assessment 1A and 1B, subjects were asked multiple choice questions about the front and side panels of the proposed labeling (System A). The front and side panels of the proposed labeling and the results of these assessments are shown below. 8 System A (proposed labeling) Front panel: Side panel: Assessment 1A: Front panel of proposed labeling Question Average score for 100 subjects (%) What is the Accuracy [within 10% of lab results] for this meter? 92 Is the Accuracy of 95 better than an Accuracy of 78? 91 An Accuracy of 95 is equal to which of the following? 97 9 Assessment 1B: Side panel of proposed labeling Question Average score for 100 subjects (%) Out of 100 tests performed, how many glucose results are within 15% of a glucose test performed in a hospital lab? 76 True or False: 78 out of 100 tests performed on this meter are within 5% of glucose testing performed in a hospital lab? 88 Out of 100 tests performed, how many glucose results are within 10% of a glucose test performed within a hospital lab? 89 According to this table, 95 out of 100 tests are within 10% of lab results. Are the other 5 tests within 10% of lab results? 52 This labeling information compares the accuracy of this glucose meter to which of the following? (Select one) 91 For assessments 2, 3, and 4, subjects were asked to compare the proposed labeling for System A to Systems B, C, or D. The side panels for Systems B, C, and D and the results of these assessments are shown below. The front panels for Systems B, C, and D (not shown) display the accuracy values within 10% of lab results (i.e., 81 out of 100 tests for System B, 89 out of 100 tests for System C, and 91 out of 100 tests for System D). System B: System C: System D: 10 Assessments 2, 3, 4: Comparison of System A to Systems B, C, or D Average score for 100 subjects (%) Question (2) System A vs. System B (3) System A vs. System C (4) System A vs. System D Which meter has a [higher or lower] Accuracy [within 10% of lab results]? If unsure, please explain. 98 97 98 When comparing the two meters for results that are within 5% of lab results, which meter is more accurate? If unsure, please explain. 91 96 89 When comparing the two meters for results that are within 10% of lab results, which meter is [less or more] accurate? If unsure, please explain. 87 93 89 When comparing the two meters for results that are within 15% of lab results, which meter is [less or more] accurate? If unsure, please explain. 71 84 96 Overall, which meter is [less or more] accurate? If unsure, please explain. 89 90 94 (Check True or False) For System A, there are more results that fall within 10% of Lab Results than results that fall within 5% of lab results? 91 93 93 (Check True or False) For System [B or C or D], there are more results that fall within 5% of Lab Results than results that fall within 10% of lab results? 75 84 83 The results for assessments 1A, 1B, 2, 3, and 4 shown above support the intended user understanding of the proposed outer carton accuracy labeling. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: The StatStrip Xpress Blood Glucose Test Strips package insert includes the following: The normal fasting adult blood Glucose range for a person without diabetes is less than 100 mg/dL. One to two hours after meals, normal blood Glucose levels should be less than 140 mg/dL. 11 From: American Diabetes Association, Standards of Medical Care in Diabetes. Diabetes Care, Vol 40, Supplement 1. January 2017. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Refer to the decision memorandum for k160156 for information related to hematocrit range, altitude, temperature and humidity, sample volume, infection control, electromagnetic compatibility, readability evaluation, and customer service. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK141689_s0_e2000

K141689.txt

purpose for submission

New assay

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Purpose for submission:

idK141689_s0_e2000

K141689.txt

measurand

C-reactive protein (CRP)

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Measurand:

idK141689_s0_e2000

K141689.txt

type of test

Quantitative

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Type of test:

idK141689_s0_e2000

K141689.txt

panel

Clinical Chemistry

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Panel:

idK141689_s0_e2000

K141689.txt

intended use

See indication for use.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Intended use:

idK141689_s0_e2000

K141689.txt

indications for use

FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer.

STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Indications for use:

idK141689_s0_e2000

K141689.txt

applicant

Qualigen, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE A. 510(k) Number: k141689 B. Purpose for Submission: New assay C. Measurand: C-reactive protein (CRP) D. Type of Test: Quantitative E. Applicant: Qualigen, Inc. F. Proprietary and Established Names: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Method Verification Kit G. Regulatory Information: 1. Regulation section: 21 CFR 866.5270 – C-reactive protein immunological test system 21 CFR 862.1150 – Calibrator 21 CFR 862.1660 – Quality Control Material (Assayed and Unassayed) 2. Classification: Class II Class II Class I, reserved 2 3. Product code: DCK – C-reactive, protein, Antigen, Antiserum JIT – Calibrator, Secondary JJX – Quality Control Material (Assayed and Unassayed) 4. Panel: Clinical Chemistry H. Intended Use: 1. Intended use(s): See indication for use. 2. Indication(s) for use: FastPack High Sensitivity C-Reactive Protein Immunoassay FastPack High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack Analyzer. Not intended for Point-of-Care use. FastPack High Sensitivity C-Reactive Protein Calibrator Kit FastPack High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Controls FastPack High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. FastPack High Sensitivity C-Reactive Protein Method Verification Kit FastPack High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack High Sensitivity C-Reactive Protein Immunoassay on the FastPack Analyzer. 3. Special conditions for use statement(s): For prescription use only. For in vitro diagnostic use only. Not intended for Point-of-Care use. 3 4. Special instrument requirements: FastPack Analyzer I. Device Description: Each FastPack High Sensitivity C-Reactive Protein Immunoassay Kit contains: · 30 FastPack High Sensitivity C-Reactive Protein Reagent Packs · Sample diluent A, 32 vials, 2.475 ml each Each FastPack High Sensitivity C-Reactive Protein Reagent Pack contains: · Paramagnetic Particles coated with streptavidin, 150 1-JL · Murine monoclonal anti-CRP antibody covalently linked to alkaline phosphatase and Murine monoclonal anti-CRP antibody covalently linked to biotin, 100 1-JL · Wash Buffer, 2.0 ml Tris buffer containing surfactants · Substrate, 145 1-JL lmmuGlow: lndoxyl-3-phosphate and lucigenin in buffer containing preservatives The test reagents include: · Conjugate solution – · a murine monoclonal anti-C-reactive protein (CRP) monoclonal antibody conjugated to alkaline phosphatase · a biotinylated murine monoclonal anti-CRP monoclonal antibody · Solid support streptavidin coated paramagnetic particles · Substrate solution – ImmuGlow · Wash solution: Tris buffer containing detergents · Sample diluent A – the defined protein (bovine serum albumin) matrix provided within the reagent kit for dilution of samples above the assay range · FastPack High Sensitivity C-Reactive Protein Calibrator Kit One level of calibrator material is provided ready to use in 1.0 mL/vial. Contains known quantities of human C-reactive protein. Contains 0.09% Sodium azide as preservative. · FastPack High Sensitivity C-Reactive Protein Control Kit Two levels of hsCRP controls are provided ready to use in 1.0 mL/vial. hsCRP controls are prepared from human plasma and human proteins. Preservatives (0.09% sodium azide) and stabilizers have been added to maintain product integrity. · FastPack High Sensitivity C-Reactive Protein Method Verification Kit Three levels (Low, Mid and High) are provided ready to use in 0.5 mL/vial. hsCRP Verifiers contain components of human origin prepared with protein stabilizers and preservatives to yield predetermined concentrations. Contains 0.09% sodium azide as preservative. The Fast Pack High Sensitivity C-Reactive Protein Calibrator Kit, Controls and Verification 4 Kit contain human source material. Each serum/plasma donor unit used in the manufacture of these products has been tested by FDA accepted methods and found non-reactive for the presence of HBsAg and antibody to HIV-1/2, HCV and HIV-1 Ag. J. Substantial Equivalence Information: 1. Predicate device name(s): · Olympus CRP Latex Reagent · Bio-Rad Laboratories Liquichek™ Cardiac Markers Plus Control · Ortho-Clinical Diagnostics, Inc. VITRO Chemistry Products hsCRP Performance Verifier, I, II, and III 2. Predicate 510(k) number(s): · k051564 · k050537 · k041799 3. Comparison with predicate: Similarities and Differences between FastPack and Olympus hsCRP Assays Item Qualigen FastPack High Sensitivity C-Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 Intended Use/ Indications for Use High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. Same Sample Type Serum or plasma (EDTA or lithium heparin) Same Reagent Storage Temperature 2-8 ºC Same Testing Environment Professional use Same Precision (% CV) Within-run: ≤ 1.0% Between-run: ≤ 5.2% Total: ≤9.0% Within-run: ≤ 3.2% Total: ≤ 3.8% Linearity Assay linear from 0.2 mg/L to 15 mg/L in high sensitivity application Assay linear from 0.2 - 160 mg/L 5 Interfering Substances/Specificity No interference found at the below tested concentrations: Bilirubin (conjugated) up to 40 mg/dL Bilirubin (unconjugated) up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Human serum albumin up to 7.7 g/dL Transferrin up to 567 mg/dL Human IgG up to 2961 μg/mL No interference found at the below tested concentrations: Bilirubin up to 40 mg/dL Hemoglobin up to 500 mg/dL Intralipid up to 1000 mg/dL Expected Values/Reference Intervals 0.2 – 11.4 mg/L Cardiac risk assessment categories: Low < 1 mg/L Average 1.0 to 3.0 mg/L High > 3.0 mg/L Methodology The FastPack High Sensitivity C-Reactive Protein Immunoassay is a paramagnetic particle, chemiluminescent immunoassay employing specific murine monoclonal antibodies. The Olympus CRP Latex reagent is a turbidimetric assay employing rabbit antibodies coated on latex particles. Assay principle Chemiluminescence Turbidimetry Assay procedure Automated Automated Assay range 0.2 - 15 mg/L for High Sensitivity Application 0.2 - 160 mg/L (provides measurements both for “Normal Application” and “Highly Sensitive Application”) Traceability Traceable to the ERM- DA474/IFCC reference which serves as the Primary Reference Material Traceable to an external standard Similarities and Differences between FastPack and Olympus CRP Calibrators Item Qualigen FastPack High-Sensitivity C- Reactive Protein Immunoassay Olympus America, Inc. CRP Latex reagent k051564 6 Intended Use/Indication for Use For in-vitro diagnostic use in calibrating C-Reactive Protein Immunoassay Same Antigen used in calibrators Human CRP Same Matrix Liquid human serum matrix containing a predetermined level of human CRP Same Storage temperature 2-8 ºC Same Number of calibrators 1 5 (additional calibrators provided at higher concentrations to enable CRP measurements in the “Normal Application”) Similarities and Differences between FastPack and Predicate CRP Controls Item Qualigen FastPack High- Sensitivity C-Reactive Protein Immunoassay Bio-Rad Laboratories Liquiche Applicant:

idK141689_s4000_e6000

K141689.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

of blank was determined from 80 replicate determinations of a blank sample tested on four different FastPack instruments using two reagent lots. The LOB was determined as the upper 95th percentile of the distribution. This value was 0.005 mg/L CRP. LoD: The LOD was estimated from 80 replicate determinations of three low samples. Per the CLSI EP17-A guideline, LOD was determined by the following equation: LOD = LOB + (cß * SDS), where cß = 1.645/(1-(1/(4 *f)), where f is the degrees of freedom, and SDS is the pooled standard deviation of the observations. In this study, the LOD was found to be 0.032 mg/L CRP. LoQ: The LoQ was determined as the lowest sample which provided <20% CV. The LOQ was set to 0.063 mg/L CRP. e. Analytical specificity: Endogenous substance interference was evaluated by spiking two serum samples (1.0 and 6.0 mg/L CRP, respectively) with hemoglobin, lipid, bilirubin, albumin, rheumatoid factor (RF), transferrin, human anti-mouse IgG HAMA and Heterophile/HAMA. The samples testing interference with hemoglobin, lipid, bilirubin, albumin, rheumatoid factor (RF), transferrin were analyzed in 5 replicate determinations using one FastPack analyzers and one lot of Fast Pack reagents. The samples testing interference with human anti-mouse IgG HAMA were tested in duplicate and samples testing interference with Heterophile/HAMA in triplicate determinations, respectively. There was no significant interference for the following endogenous substances in the ranges tested below: Bilirubin up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Albumin up to 7.7 g/dL Rheumatoid factor (RF) up to 1000 IU/mL Transferrin up to 567 mg/dL Human IgG up to 2961 mg/mL Human anti-mouse IgG HAMA up to 4 mg/dL Heterophile/HAMA up to 3641 ng/mlL. 11 The sponsor also tested potential interference to the exogenous substances in 5 replicate determinations using one FastPack analyzer and one lot of Fast Pack reagents. No significant interference was found when these substances were tested in the concentration ranges indicated below: L-Ascorbic Acid up to 200 mg/L Oxaloacetic Acid up to 300 mM Glutathione up to 300 mM Isoniazid up to 300 mM L-DOPA up to 300 mM The sponsor’s definition of non-significant interference is <10% difference between the spiked and unspiked samples. The labeling includes a limitation that heterophilic antibodies may interfere with this method. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: In this method comparison study, one hundred and thirty three human serum samples with CRP values across the measuring range were analyzed on the candidate device and the results were compared to those determined with the predicate device. Deming regression results from the method comparison study are summarized in the table below: No. Samples Range Tested (mgl/L) Slope (95% CI) y-intercept (95% CI) R (95% CI) 143 0.21 – 15.00 0.98 (0.95-1.01) -0.12 (-0.21 to -0.02) 0.99 (0.99 - 0.99) b. Matrix comparison: Serum and lithium-heparin plasma The sponsor performed a matrix comparison study to assess the performance of the assay when different sample types/tubes (serum vs. EDTA plasma and. Lithium Heparin plasma) were tested. Forty one human blood samples were processed to serum, lithium-heparin plasma, or EDTA plasma in parallel. The samples were then 12 tested in duplicate determinations each in the FastPack High Sensitivity C-Reactive Protein Immunoassay using two lots of FastPack Reagents and one lot of calibrators. The data analysis was performed using singlicate results. Deming regression results for comparisons of EDTA and lithium-heparin plasma to serum are summarized in tables below: Comparison of serum and EDTA plasma: Parameter Result N compared 41 Range of observations, mg/L Serum: 0.33 – 14.72 EDTA Plasma: 0.29 – 14.76 Absolute bias, mg/L -0.225 % Bias -6.1 Deming regression results Slope 0.94 y-intercept 0.0 R 0.984 R2 0.967 Comparison of serum and Lithium-Heparin plasma: Parameter Result N compared 41 Range of observations, mg/L Serum: 0.33 – 14.72 Lithium-Heparin Plasma: 0.31 – 14.86 Absolute bias, mg/L 0.002 % Bias 0.5 Deming regression results Slope 1.00 y-intercept 0.00 R 0.993 R2 0.986 The studies support the sponsor’s claims that EDTA and Lithium-Heparin are acceptable anticoagulants to be used with The FastPack hsCRP Assay. 13 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: A reference interval study was carried out with serum samples from 211 subjects representing 4 different geographic regions of the United States yielded the results in the table below. The non-parametric 2.5th - 97.5th percentile of 0.2 - 11.4 mg/L provides the reference interval determined from this study, which is in accord with literature1-4. Observed values Mean (SD) 3.2 (3.1) mg/L Median (Min - Max) 1.9 (0.2 - 13.1) mg/L 2.5th - 97.5th percentile 0.2 - 11.4 mg/L Newborns with no evidence of infection have CRP concentrations of< 2 mg/L.5 References: 1 Aziz N, Fahey JL, Detels R, Butch AW. Analytical performance of a highly sensitive C-reactive protein-based immunoassay and the effects of laboratory variables on levels of protein in blood. Clinical and Diagnostic Laboratory Immunology 2003;10:652-7. 2 Imhof A, Frohlich M, Loewel H, et al. Distributions of C-reactive protein measured by high-sensitivity assays in apparently healthy men and women from different populations in Europe. Clin Chem 2003;49:669-72. 3 Sennels HP, Jacobsen S, Jensen T, et al. Biological variation and reference intervals for circulating osteopontin, osteoprotegerin, total soluble receptor activator of nuclear factor kappa B ligand and high-sensitivity C-reactive protein. Scand J Clin Lab Invest 2007;67:821-35. 4 Charuruks N, Laohajinda B, Rujiwanitgun S, Chaiworaporn M. Reference interval for C-reactive protein and its distribution pattern in thai adults. Circ J 2005;69:339-44. 5 Soldin OP, Bierbower LH, Choi JJ, et al. Serum iron, ferritin, transferrin, total iron 14 binding capacity, hs-CRP, LDL cholesterol and magnesium in children; new reference intervals using the Dade Dimension Clinical Chemistry System; Clin Chim Acta 2004;342:211-7. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK141689_s4000_e6000

K141689.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

the limit of blank was determined from 80 replicate determinations of a blank sample tested on four different FastPack instruments using two reagent lots. The LOB was determined as the upper 95th percentile of the distribution. This value was 0.005 mg/L CRP. LoD: The LOD was estimated from 80 replicate determinations of three low samples. Per the CLSI EP17-A guideline, LOD was determined by the following equation: LOD = LOB + (cß * SDS), where cß = 1.645/(1-(1/(4 *f)), where f is the degrees of freedom, and SDS is the pooled standard deviation of the observations. In this study, the LOD was found to be 0.032 mg/L CRP. LoQ: The LoQ was determined as the lowest sample which provided <20% CV. The LOQ was set to 0.063 mg/L CRP. e. Analytical specificity: Endogenous substance interference was evaluated by spiking two serum samples (1.0 and 6.0 mg/L CRP, respectively) with hemoglobin, lipid, bilirubin, albumin, rheumatoid factor (RF), transferrin, human anti-mouse IgG HAMA and Heterophile/HAMA. The samples testing interference with hemoglobin, lipid, bilirubin, albumin, rheumatoid factor (RF), transferrin were analyzed in 5 replicate determinations using one FastPack analyzers and one lot of Fast Pack reagents. The samples testing interference with human anti-mouse IgG HAMA were tested in duplicate and samples testing interference with Heterophile/HAMA in triplicate determinations, respectively. There was no significant interference for the following endogenous substances in the ranges tested below: Bilirubin up to 40 mg/dL Hemoglobin up to 750 mg/dL Lipids up to 1000 mg/dL Albumin up to 7.7 g/dL Rheumatoid factor (RF) up to 1000 IU/mL Transferrin up to 567 mg/dL Human IgG up to 2961 mg/mL Human anti-mouse IgG HAMA up to 4 mg/dL Heterophile/HAMA up to 3641 ng/mlL. 11 The sponsor also tested potential interference to the exogenous substances in 5 replicate determinations using one FastPack analyzer and one lot of Fast Pack reagents. No significant interference was found when these substances were tested in the concentration ranges indicated below: L-Ascorbic Acid up to 200 mg/L Oxaloacetic Acid up to 300 mM Glutathione up to 300 mM Isoniazid up to 300 mM L-DOPA up to 300 mM The sponsor’s definition of non-significant interference is <10% difference between the spiked and unspiked samples. The labeling includes a limitation that heterophilic antibodies may interfere with this method. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: In this method comparison study, one hundred and thirty three human serum samples with CRP values across the measuring range were analyzed on the candidate device and the results were compared to those determined with the predicate device. Deming regression results from the method comparison study are summarized in the table below: No. Samples Range Tested (mgl/L) Slope (95% CI) y-intercept (95% CI) R (95% CI) 143 0.21 – 15.00 0.98 (0.95-1.01) -0.12 (-0.21 to -0.02) 0.99 (0.99 - 0.99) b. Matrix comparison: Serum and lithium-heparin plasma The sponsor performed a matrix comparison study to assess the performance of the assay when different sample types/tubes (serum vs. EDTA plasma and. Lithium Heparin plasma) were tested. Forty one human blood samples were processed to serum, lithium-heparin plasma, or EDTA plasma in parallel. The samples were then 12 tested in duplicate determinations each in the FastPack High Sensitivity C-Reactive Protein Immunoassay using two lots of FastPack Reagents and one lot of calibrators. The data analysis was performed using singlicate results. Deming regression results for comparisons of EDTA and lithium-heparin plasma to serum are summarized in tables below: Comparison of serum and EDTA plasma: Parameter Result N compared 41 Range of observations, mg/L Serum: 0.33 – 14.72 EDTA Plasma: 0.29 – 14.76 Absolute bias, mg/L -0.225 % Bias -6.1 Deming regression results Slope 0.94 y-intercept 0.0 R 0.984 R2 0.967 Comparison of serum and Lithium-Heparin plasma: Parameter Result N compared 41 Range of observations, mg/L Serum: 0.33 – 14.72 Lithium-Heparin Plasma: 0.31 – 14.86 Absolute bias, mg/L 0.002 % Bias 0.5 Deming regression results Slope 1.00 y-intercept 0.00 R 0.993 R2 0.986 The studies support the sponsor’s claims that EDTA and Lithium-Heparin are acceptable anticoagulants to be used with The FastPack hsCRP Assay. 13 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: A reference interval study was carried out with serum samples from 211 subjects representing 4 different geographic regions of the United States yielded the results in the table below. The non-parametric 2.5th - 97.5th percentile of 0.2 - 11.4 mg/L provides the reference interval determined from this study, which is in accord with literature1-4. Observed values Mean (SD) 3.2 (3.1) mg/L Median (Min - Max) 1.9 (0.2 - 13.1) mg/L 2.5th - 97.5th percentile 0.2 - 11.4 mg/L Newborns with no evidence of infection have CRP concentrations of< 2 mg/L.5 References: 1 Aziz N, Fahey JL, Detels R, Butch AW. Analytical performance of a highly sensitive C-reactive protein-based immunoassay and the effects of laboratory variables on levels of protein in blood. Clinical and Diagnostic Laboratory Immunology 2003;10:652-7. 2 Imhof A, Frohlich M, Loewel H, et al. Distributions of C-reactive protein measured by high-sensitivity assays in apparently healthy men and women from different populations in Europe. Clin Chem 2003;49:669-72. 3 Sennels HP, Jacobsen S, Jensen T, et al. Biological variation and reference intervals for circulating osteopontin, osteoprotegerin, total soluble receptor activator of nuclear factor kappa B ligand and high-sensitivity C-reactive protein. Scand J Clin Lab Invest 2007;67:821-35. 4 Charuruks N, Laohajinda B, Rujiwanitgun S, Chaiworaporn M. Reference interval for C-reactive protein and its distribution pattern in thai adults. Circ J 2005;69:339-44. 5 Soldin OP, Bierbower LH, Choi JJ, et al. Serum iron, ferritin, transferrin, total iron 14 binding capacity, hs-CRP, LDL cholesterol and magnesium in children; new reference intervals using the Dade Dimension Clinical Chemistry System; Clin Chim Acta 2004;342:211-7. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK150168_s0_e2000

K150168.txt

purpose for submission

New Device

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Purpose for submission:

idK150168_s0_e2000

K150168.txt

measurand

Tacrolimus

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Measurand:

idK150168_s0_e2000

K150168.txt

type of test

Quantitative immunoassay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Type of test:

idK150168_s0_e2000

K150168.txt

product code

MLM, JIT

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Product code:

idK150168_s0_e2000

K150168.txt

panel

Toxicology (91)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Panel:

idK150168_s0_e2000

K150168.txt

intended use

See indications for use below.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Intended use:

idK150168_s0_e2000

K150168.txt

predicate device name

ARCHITECT Tacrolimus Assay

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Predicate device name:

idK150168_s0_e2000

K150168.txt

applicant

Siemens Healthcare Diagnostics, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k150168 B. Purpose for Submission: New Device C. Measurand: Tacrolimus D. Type of Test: Quantitative immunoassay E. Applicant: Siemens Healthcare Diagnostics, Inc. F. Proprietary and Established Names: Dimension Tacrolimus Flex® Reagent Cartridge (TAC) Dimension Tacrolimus Calibrator (TAC CAL) G. Regulatory Information: 1. Regulation section: 21 CFR §862.1678, Tacrolimus Test System 21 CFR §862.1150, Calibrator 2. Classification: Class II 3. Product code: MLM, JIT 2 4. Panel: Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. 3. Special conditions for use statement(s): Prescription use only The instrument reporting system contains flags and comments to provide the user with information regarding instrument processing errors, instrument status information and potential errors in TAC results. Refer to the Dimension® Operator’s Guide for the meaning of report flags and comments. Any result containing flags and/or comments should be addressed according to your laboratory’s procedure manual. Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. Antibodies to ß-galactosidase can be encountered in samples as a consequence of bacterial infection and may produce falsely elevated results which may not be consistent with clinical evaluation. The assay has been designed to minimize interference from antibodies to ß-galactosidase. In very rare instances, immunoassays may produce falsely elevated or decreased results due to other patient-specific interferents. A number of these interferents are present in the plasma of affected patient samples and will be detected by the automatic rerun procedure. Complete elimination of such interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Confirmation of unexpected or atypical results by an alternative methodology is recommended prior to any adjustments in tacrolimus dosage. For patients with impaired liver function and patients receiving other drugs which may induce or inhibit microsomal enzyme activity, the routine use of the Dimension® Tacrolimus assay may be supported by HPLC data to assess possible changes in biotransformation and elimination. 3 If TACR (Cat.No. DF107) and TAC (Cat. No. DF207) assays are processed on the same instrument, there is a remote potential for carryover from the TACR pretreatment reagent to produce falsely elevated results with the TAC assay. This potential has been mitigated as much as possible through the instrument software. If use of the TAC and TACR assays on the same instrument cannot be avoided, as a further safeguard, each run of the TAC assay should be immediately preceded by flushing the reagent and sample probes (10 cycles) using the Prime Pump routine (SYSTEM PREP, PUMP PRIME, PRIME WATER). TAC reagent hydrations should also be preceded by flushing of the probes using this routine. Laboratories should convert as rapidly as possible to consistent use of the TAC assay for individual patients, discontinue use of the TACR assay and remove any remaining TACR reagent from the instrument inventory. 4. Special instrument requirements: The Dimension® clinical chemistry system I. Device Description: The automated Dimension® TAC method is performed using a method specific Flex® reagent cartridge. The reagents for this assay are packaged in an 8-well Flex® Reagent Cartridge that contains a pretreatment reagents, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The product is provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. The calibrators are packaged at 1.0 mL per vial for levels 2 – 5. Level 1, calibrator base with no tacrolimus has 2.0 mL per vial so that it can also be used as a high sample diluent. Each level of TAC Calibrator is prepared from human whole blood hemolysate base. Levels 2 – 5 are spiked with purified tacrolimus drug to achieve target concentrations of 3 ± 1 ng/mL; 6 ± 1ng/mL; 12 ± 2ng/mL and >30.0 ng/mL. Level 1 calibrator has no drug added. The calibrator package insert contains the following caution: “Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV- 2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion”. J. Substantial Equivalence Information: 1. Predicate device name(s): 4 ARCHITECT Tacrolimus Assay 2. Predicate 510(k) number(s): k070820 3. Comparison with predicate: Item Device Dimension® TAC Flex® reagent cartridge Predicate ARCHITECT Tacrolimus Assay (k070820) Similarities Intended Use For the quantitative measurement of tacrolimus in human whole blood as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients Same Assay type Immunoassay Same Sample Type Whole blood in EDTA Same High Sample Dilution Manual Same Differences Instrument The Dimension® clinical chemistry system The Abbott ARCHITECT i System Sample Pretreatment No manual pretreatment Manual pre-treatment Measuring Range 1.0 – 30 ng/mL 2 – 30 ng/mL Cross reactivity Profile M-I M-II M-III M-IV M-V M-VI M-VII M-VIII 1% 18% 15% 99% 1% 1% 43% 0% 8% 94% 45% 9% Not Available Not Available Not Available Not Available Item Device TAC CAL Predicate TACR CAL (k060503) Similarities Intended Use For the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system. Same Form Frozen Liquid Same 5 Matrix Whole blood hemolysate Same Levels Five Same Traceability Purified tacrolimus Same Differences Assignment Assigned for Dimension® TAC Assigned for Dimension® TACR Target Concentration Range Level 1: - 0.5 to + 0.5 ng/mL Level 2: 2.7 to 4.2 ng/mL Level 3: 5.8 to 7.3 ng/mL Level 4: 11.6 to 13.6 ng/mL Level 5: ≥30.0 ng/mL Level A: - 0.7 to + 0.7 ng/mL Level 2: 2.5 to 4.0 ng/mL Level 3: 5.5 to 7.0 ng/mL Level 4: 11.0 to 13.0 ng/mL Level 5: 31.0 to 34.0 ng/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods · CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach · CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline- Second Edition · CLSI EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved GuidelineCLSIEP17-A2,Evaluation of Detection Capability for ClinicalLaboratory Measurement Procedures; Approved Guideline · FDA Guidance document “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA” – 09/16/2002. L. Test Principle: The Dimension® TAC method is an automated immunoassay in which free and tacrolimus- bound antibody- Applicant:

idK150168_s6000_e8000

K150168.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

ECT Tacrolimus (k070820) Total 96 1.11 -0.93 -0.22 0.69 0.984 Kidney only 48 1.08 -0.82 -0.13 0.84 0.978 Liver only 48 1.11 -0.95 -0.32 0.50 0.993 Site3/lot3 Proposed TAC Assay versus n Slope Intercept Mean Bias Std Dev. R2 LCMS Total 114 1.05 -0.41 -0.33 1.32 0.945 Kidney only 59 1.13 -1.34 -0.68 1.53 0.922 Liver only 55 1.09 -0.33 0.05 0.91 0.974 Abbott ARCHITECT Tacrolimus (k070820) Total 110 0.90 -0.05 -0.85 0.90 0.983 Kidney only 56 0.95 -0.44 -0.86 0.77 0.982 Liver only 54 0.85 0.21 -0.84 1.02 0.988 b. Matrix comparison: Not applicable. The assay is intended for use with EDTA whole blood only. 14 3. Clinical studies: a. Clinical Sensitivity: NA b. Clinical specificity: NA c. Other clinical supportive data (when a. and b. are not applicable): NA 4. Clinical cut-off: Not applicable; this is a quantitative assay. 5. Expected values/Reference range: The following is stated in the package insert: No firm therapeutic range exists for tacrolimus in whole blood. The complexity of the clinical state, individual differences in sensitivity to immunosuppressive and nephrotoxic effects of tacrolimus, co-administration of other immunosuppressants, type of transplant, time post-transplant, and a number of other factors will cause different requirements for optimal blood levels of tacrolimus. Individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made. Each assay user must establish therapeutic ranges based on clinical experience. Therapeutic ranges vary according to the commercial test method used, and therefore should be established for each commercial test. Values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and cross-reactivity with metabolites, nor should correction factors be applied. Therefore, consistent use of one assay for individual patients is recommended. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK150168_s6000_e8000

K150168.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

CHITECT Tacrolimus (k070820) Total 96 1.11 -0.93 -0.22 0.69 0.984 Kidney only 48 1.08 -0.82 -0.13 0.84 0.978 Liver only 48 1.11 -0.95 -0.32 0.50 0.993 Site3/lot3 Proposed TAC Assay versus n Slope Intercept Mean Bias Std Dev. R2 LCMS Total 114 1.05 -0.41 -0.33 1.32 0.945 Kidney only 59 1.13 -1.34 -0.68 1.53 0.922 Liver only 55 1.09 -0.33 0.05 0.91 0.974 Abbott ARCHITECT Tacrolimus (k070820) Total 110 0.90 -0.05 -0.85 0.90 0.983 Kidney only 56 0.95 -0.44 -0.86 0.77 0.982 Liver only 54 0.85 0.21 -0.84 1.02 0.988 b. Matrix comparison: Not applicable. The assay is intended for use with EDTA whole blood only. 14 3. Clinical studies: a. Clinical Sensitivity: NA b. Clinical specificity: NA c. Other clinical supportive data (when a. and b. are not applicable): NA 4. Clinical cut-off: Not applicable; this is a quantitative assay. 5. Expected values/Reference range: The following is stated in the package insert: No firm therapeutic range exists for tacrolimus in whole blood. The complexity of the clinical state, individual differences in sensitivity to immunosuppressive and nephrotoxic effects of tacrolimus, co-administration of other immunosuppressants, type of transplant, time post-transplant, and a number of other factors will cause different requirements for optimal blood levels of tacrolimus. Individual tacrolimus values cannot be used as the sole indicator for making changes in the treatment regimen. Each patient should be thoroughly evaluated clinically before treatment adjustments are made. Each assay user must establish therapeutic ranges based on clinical experience. Therapeutic ranges vary according to the commercial test method used, and therefore should be established for each commercial test. Values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and cross-reactivity with metabolites, nor should correction factors be applied. Therefore, consistent use of one assay for individual patients is recommended. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK163626_s0_e2000

K163626.txt

purpose for submission

Clearance of the ARIES Bordetella Assay for use with ARIES Systems.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Purpose for submission:

idK163626_s0_e2000

K163626.txt

measurand

Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes.

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Measurand:

idK163626_s0_e2000

K163626.txt

type of test

Qualitative real-time polymerase chain reaction.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Type of test:

idK163626_s0_e2000

K163626.txt

classification

Class II

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Classification:

idK163626_s0_e2000

K163626.txt

product code

OZZ

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Product code:

idK163626_s0_e2000

K163626.txt

panel

Microbiology (83)

(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Panel:

idK163626_s0_e2000

K163626.txt

intended use

The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Intended use:

idK163626_s0_e2000

K163626.txt

predicate device name

illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Predicate device name:

idK163626_s0_e2000

K163626.txt

applicant

Luminex Corporation

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Applicant:

idK163626_s0_e2000

K163626.txt

proprietary and established names

ARIES Bordetella Assay

ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Proprietary and established names:

idK163626_s0_e2000

K163626.txt

regulation section

866.3980

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K163626 B. Purpose for Submission: Clearance of the ARIES Bordetella Assay for use with ARIES Systems. C. Measurand: Bordetella pertussis toxin promoter, Bordetella parapertussis IS1001 insertion element in respective genomes. D. Type of Test: Qualitative real-time polymerase chain reaction. E. Applicant: Luminex Corporation F. Proprietary and Established Names: ARIES Bordetella Assay G. Regulatory Information: 1. Regulation section: 866.3980 Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product code: OZZ 2 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. 2. Indication(s) for use: Same as intended use. 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: For use with the ARIES Systems. I. Device Description: The ARIES Bordetella Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test system that consists of the ARIES System or the ARIES M1 System with their included ARIES Software, an assay-specific cassette, and an assayspecific protocol file. The ARIES Bordetella Assay cassette is a disposable, single-use cassette containing nucleic acid 3 purification reagents, internal sample process control (SPC), and an assay-specific master mix capable of performing the designated assay on one sample. The ARIES Bordetella Assay cassette directly detects and identifies B. pertussis and B. parapertussis DNA from nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region. Nasopharyngeal swab specimens are collected from patients using a commercially available nasopharyngeal swab placed into transport media (i.e. Universal Transport Media (UTM), ESwab, M5, M6). The specimen is then transported to the laboratory for testing. The specimen is lysed and nucleic acid is extracted using the ARIES system. The ARIES system subsequently performs PCR amplification of target sequences, and assay fluorescence is monitored via distinct fluorophore labels on primer pairs. As the reaction is slowly heated the fluorescent-quencher labeled strands separate, and a maximum fluorescence is observed. The instrument fluorescence output is analyzed, and test results are determined using the ARIES System software and the ARIES Bordetella Assay protocol and run files. J. Substantial Equivalence Information: 1. Predicate device name(s): illumigene Pertussis DNA Amplification Assay (Meridian Bioscience, Inc.) 2. Predicate 510(k) number(s): K133673 3. Comparison with predicate: Similarities Item Device Predicate (K133673) Intended Use The ARIES Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The ARIES Bordetella Assay targets the B. pertussis toxin promoter and the B. parapertussis IS1001 insertion element in the genomes. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. 4 Similarities Item Device Predicate (K133673) other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the ARIES Bordetella Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out coinfections with other respiratory pathogens. The direct detection and identification of B. pertussis and B. parapertussis nucleic acids from symptomatic patients aids in the diagnosis of B. pertussis and B. parapertussis respiratory infection in conjunction with other clinical findings and epidemiological information. The ARIES Bordetella Assay is indicated for use with the ARIES Systems. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Sample type Nasopharyngeal swabs (NPS) Nasopharyngeal swabs (NPS) Assay results Qualitative Qualitative Analyte DNA DNA Differences Item Device Predicate Extraction Method Automated by the ARIES Systems Manual extraction Organisms Detected B. pertussis and B. parapertussis Bordetella pertussis B. pertussis Target Toxin promoter (ptxA-pr) IS481 Insertional Element B. parapertussis Target IS1001 insertion element N/A Detection Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Measurement of magnesium pyrophosphate forming a precipitate in the reaction mixture. 5 Differences Item Device Predicate Detection Visible Light Transmission Assay format Real-time PCR DNA Amplification; Loop-Mediated Isothermal Amplification (LAMP) Controls Internal Control: Sample processing control (SPC) Internal Control Provided; External positive control included in illumigene Pertussis External Control Kit Instrument ARIES System, ARIES M1 System illumipro-10 K. Standard/Guidance Document Referenced (if applicable): Not applicable L. Test Principle: The ARIES Bordetella Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair—2'-deoxy-5-methyl-isocytidine (iC):2'- deoxyisoguanosine (iG). The isobases Regulation section:

idK163626_s18000_e20000

K163626.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

system measures the SPC temperature and fluorescence intensity to ensure the thermal and optical subsystems remain calibrated. 6. Quality Control: An extractable sample processing control (SPC) target is present in the ARIES Bordetella Assay cassette and is processed with the specimen. The SPC monitors specimen lysis, recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. 33 P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: N/A Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK163626_s18000_e20000

K163626.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

, the system measures the SPC temperature and fluorescence intensity to ensure the thermal and optical subsystems remain calibrated. 6. Quality Control: An extractable sample processing control (SPC) target is present in the ARIES Bordetella Assay cassette and is processed with the specimen. The SPC monitors specimen lysis, recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. 33 P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: N/A Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK152386_s0_e2000

K152386.txt

purpose for submission

This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients.

STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Purpose for submission:

idK152386_s0_e2000

K152386.txt

type of test

Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Type of test:

idK152386_s0_e2000

K152386.txt

classification

Class II

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Classification:

idK152386_s0_e2000

K152386.txt

panel

Microbiology (83)

k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Panel:

idK152386_s0_e2000

K152386.txt

applicant

Luminex Molecular Diagnostics, Inc.

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Applicant:

idK152386_s0_e2000

K152386.txt

proprietary and established names

NxTAG® Respiratory Pathogen Panel

IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Proprietary and established names:

idK152386_s0_e2000

K152386.txt

regulation section

21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K152386 B. Purpose for Submission: This is a new 510(k) application for a qualitative Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay used with the MAGPIX instrument for the in vitro qualitative detection of Influenza A virus (with subtype differentiation), Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae in nasopharyngeal swab (NPS) specimens from symptomatic human patients. C. Measurand: Influenza A RNA: Flu A Matrix (M) gene, Flu A H1 (HA) gene, Flu A H3 (HA) gene Influenza B RNA: Flu B Matrix (M) gene RSV A and RSV B: RNA L Polymerase gene Coronaviruses 229E, OC43 and NL63 RNA: Nucleocapsidprotein (N) gene Coronavirus HKU1: open reading frame 1 ab Human Metapneumovirus RNA: Phosphoprotein (P) gene Rhinovirus/Enterovirus RNA: 5’-UTR Adenovirus DNA: Hexon gene Parainfluenza virus RNA: Parainfluenza 1 HN gene, Parainfluenza 2 and 3 NP gene, Parainfluenza virus 4 phosphoprotein (P) gene Human Bocavirus DNA: NP1 gene Chlamydophila pneumoniae DNA: rpoB gene Mycoplasma pneumoiae DNA: P1 gene D. Type of Test: Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) E. Applicant: Luminex Molecular Diagnostics, Inc. F. Proprietary and Established Names: NxTAG® Respiratory Pathogen Panel 2 G. Regulatory Information: 1. Regulation section: 21 CFR 866.3980, Respiratory viral panel multiplex nucleic acid assay 2. Classification: Class II 3. Product codes: OCC - Respiratory virus panel nucleic acid assay system OOI - Real time nucleic acid amplification system OEM - Human Metapneumovirus RNA assay system OOU - Parainfluenza multiplex nucleic acid system OEP - Influenza A Virus subtype differentiation nucleic acid assay OTG - Non-Sars Coronavirus multiplex nucleic acid assay OZY - Chlamydophila pneumoniae DNA assay system OZX - Mycoplasma pneumoniae DNA assay system 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or 3 other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): Prescription use only 4. Special instrument requirements: MAGPIX® Instrument I. Device Description: The NxTAG Respiratory Pathogen Panel (RPP) is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of respiratory tract infection. It incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction with the Luminex proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Samples are extracted using the IVD‐labeled bioMérieux NucliSENS® easyMag® system. Extracted total nucleic acid is then added to the sealed 96‐well micro plate by piercing the seal with pipette tips. Each reaction well is pre‐plated with two Lyophilized Bead Reagents (LBRs) that contain all the required reagents including primer mixes, bead mix, and enzyme buffer systems. Once the LBRs are resuspended, 4 the reaction wells are re‐sealed using the foils provided in the kit. The sealed plate can then be placed inside the thermocycler. The reaction is amplified via RT‐PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction wells. The hybridized, tagged beads are then sorted and read on the Luminex MAGPIX instrument. The MAGPIX instrument generates a signal in the form of a median fluorescence intensity (MFI) value for each bead population. The signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a qualitative call for each of the 20 targets and internal controls within each reaction well. Quality Control The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument, and is not provided as part of the NxTAG RPP. Bacteriophage MS2 is the internal control for the assay. This internal positive control is added to each specimen prior to extraction. This internal control allows the user to ascertain whether the assay is functioning properly. Failure to detect the MS2 control indicates a failure at either the extraction step, the reverse-transcription step, or the PCR step, and may be indicative of the presence of amplification inhibitors. RNase-free water is used as a no template control (NTC). Sample collection media used from the starting extraction point functions as a negative extraction control (NEC). Results Interpretation The NxTAG RPP Assay has two separate probes for detection of Influenza A H1 (H1 and H1 2009-specific). These have been combined into a single call (positive for either is positive for Influenza A subtype H1) because the Influenza A 2009 H1N1 strain has stabilized and is now considered to be the seasonal strain. Results interpretation for Influenza A and subtypes are listed in Table 1. All other analytes detected by the NxTAG RPP assay are positive if their respective channels are positive in a valid test. The results are interpreted by the xPONENT software on the MAGPIX Instrument and are exported as a CSV file to the SYNCT software where the results can be viewed by the user on the Results Page. Table 1 – All possible test results for Influenza A Final Result Influenza A H1-A (H1) H1-B (2009 H1N1) H3 Required follow up Influenza A Not Detected Negative Negative Negative Negative None Influenza A H1 Positive Positive Negative Negative None Positive Positive Positive Negative Positive Negative Positive Negative Negative2 Positive Negative Negative Negative2 Positive Positive Negative 5 Negative2 Negative Positive Negative Influenza A H3 Positive Negative Negative Positive None Negative2 Negative Negative Positive Influenza A H1 Regulation section:

idK152386_s2000_e4000

K152386.txt

predicate device name

BioFire Diagnostics, LLC FilmArray® Respiratory Panel

3 Positive Positive Negative Positive None Positive Negative Positive Positive Negative2 Positive Negative Positive Negative2 Negative Positive Positive Influenza A (so subtype detected) Positive Negative Negative Negative Retest1 1 If the retest provides the same result for influenza A (no subtype detected), contact local or state public health authorities for confirmatory testing. 2Detection of Influenza A/H1 or Influenza A/H3 subtypes without an Influenza A “Positive” result may occur at low titer of the virus in the specimen or may indicate a false positive due to contamination. The result could also indicate potential genetic mutations in the Matrix protein gene among circulating seasonal Influenza A viruses. J. Substantial Equivalence Information: 1. Predicate device name(s): BioFire Diagnostics, LLC FilmArray® Respiratory Panel 2. Predicate 510(k) number(s): K120267 3. Comparison with predicate: Table 2 – Assay Comparison with Predicate Device Item Subject Device (K152386) NxTAG RPP Predicate (K120267) FilmArray Respiratory Panel 510(k) Number K152386 K120267 Regulation 866.3980 Same Product Code OCC, OEM, OOU, OEP, OTG, OOI, OZY, OZX OCC, OEM, OOU, OEP, OTG, NXD, OOI, OZZ, OZY, OZX Device Class II Same Technology Principle of Operation Multiplex real time RT-PCR followed by detection of fluorescently labeled products coupled to magnetic beads Multiplex real time RT-PCR followed by high resolution melting analysis to confirm identity of amplified product Intended Use NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® Instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray instrument for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) 6 extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. The organism types and subtypes detected by the test are Influenza A, Influenza A H1, Influenza A H3, Influenza B, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus HKU1, Human Metapneumovirus, Rhinovirus/ Enterovirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The test is indicated as an aid in the detection and identification of viral and bacterial agents causing respiratory tract infections in symptomatic adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected respiratory tract infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other pathogens. The agent detected may not be the definite cause of disease. The use of additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) and clinical presentation must be taken into consideration in order to obtain the final diagnosis of respiratory tract infection. Performance characteristics for influenza A were established using specimens obtained during the obtained from individuals suspected of respiratory tract infections. The following organism types and subtypes are identified using the FilmArray RP: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co‐infection with other organisms: the agent(s) detected by the Film Array RP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetella pertussis, Coronavirus 229E, Coronavirus OC43, Influenza A/H1, Influenza A/H3, Influenza A/2009 H1, Influenza B, Mycoplasma pneumoniae Parainfluenza Virus 1, Parainfluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. Performance characteristics for 7 2013/2014 and 2014/2015 influenza seasons when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Chlamydophila pneumoniae were established primarily using contrived clinical specimens. Due to the genetic similarity between human Rhinovirus and Enterovirus, the FilmArray RP cannot reliably differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed‐up using an alternate method (e.g., cell culture or sequence analysis). The FilmArray RP detects Adenovirus species C serotype 2 and serotype 6 with reduced sensitivity. It is recommended that specimens found to be negative for Adenovirus after examination using FilmArray RP be confirmed by an alternate method (e.g., FDA cleared molecular test or cell culture). The FilmArray RP assay for coronavirus OC43 may cross‐react with some isolates of Coronavirus HKU1. A dual positive result may be due to cross‐reactivity or may indicate a co‐infection. Performance characteristics for influenza A were established when influenza A/2009 H1N1, A/H1, and A/H3 were the predominant influenza A viruses in circulation. Performance of detecting influenza A may vary if other influenza A strains are circulating or a novel influenza A virus emerges. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. Indication for Use Same as device Intended Use Same as device Intended Use Specimen Types Nasopharyngeal swab specimens (NPS) Same Nucleic Acid Extraction Yes Same 8 Extraction Methods bioMérieux NucliSENS easyMag system FilmArray RP assay Assay Results Qualitative Same Instrument System MAGPIX Instrument FilmArray Instrument K. Standard/Guidance Document Referenced (if applicable): 1. FDA Guidance: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; issued Auguest 27, 2014. 2. FDA Guidance: Respiratory Viral Panel Multiplex Nucleic Acid Assay; issued Oct 9, 2009. 3. FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; issued May 11, 2005. 4. FDA Guidance: Format for Traditional and Abbreviated 510(k); issued August 12, 2005. 5. FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; issued October 2, 2014 6. FDA Guidance: The New 510(k) Paradigm ‐ Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; issued March 20, 1998. 7. FDA Guidance: Predicate device name:

idK152386_s40000_e42000

K152386.txt

proposed labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

% 1 0.7% Rhinovirus/ Enterovirus 195 20.9 % 76 30.6 % 57 37.7% 45 25.0 % 11 5.2% 6 4.2% Human Metapneu movirus 88 9.4% 34 13.7 % 21 13.9% 14 7.8% 9 4.2% 10 7.0% Human Bocavirus 28 3.0% 16 6.5% 10 6.6% 2 1.1% 0 0.0% 0 0.0% C. pneumonia e 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% M. pneumonia e 3 0.3% 0 0.0% 2 1.3% 1 0.6% 0 0.0% 0 0.0% 1One (1) specimen generated Influenza A un-subtypeable result by NxTAG RPP (i.e. Influenza A matrix positive but H1 and H3 subtype negative). This specimen was negative for Influenza A H1 and H3 by comparator. Two (2) Influenza A positive specimens generated both H1 and H3 positive calls by NxTAG RPP. 68 Table 72 - Expected Values for NxTAG RPP Clinical Samples (Jan 2015 – Mar 2015) Target (Analyte) Overall (n=1198) 0-1 year (n=205) >1-5 years (n=99) >5-21 years (n=173) >21-65 years (n=372) >65 years (n=349) No. EV No. EV No. EV No. EV No. EV No. EV Adenovirus 36 3.0% 7 3.4% 8 8.1% 6 3.5% 6 1.6% 9 2.6% Influenza A 2251 18.8% 9 4.4% 16 16.2% 40 23.1% 80 21.5% 80 22.9% Influenza A H1 3 0.3% 1 0.5% 0 0.0% 0 0.0% 2 0.5% 0 0.0% Influenza A H3 217 18.1% 8 3.9% 15 15.2% 39 22.5% 75 20.2% 80 22.9% Influenza B 49 4.1% 2 1.0% 3 3.0% 21 12.1% 13 3.5% 10 2.9% Respiratory Syncytial Virus A 69 5.8% 28 13.7% 8 8.1% 5 2.9% 12 3.2% 16 4.6% Respiratory Syncytial Virus B 64 5.3% 31 15.1% 8 8.1% 4 2.3% 9 2.4% 12 3.4% Parainfluen za 1 4 0.3% 1 0.5% 1 1.0% 0 0.0% 0 0.0% 2 0.6% Parainfluen za 2 2 0.2% 0 0.0% 0 0.0% 0 0.0% 1 0.3% 1 0.3% Parainfluen za 3 35 2.9% 17 8.3% 2 2.0% 1 0.6% 7 1.9% 8 2.3% Parainfluen za 4 10 0.8% 1 0.5% 2 2.0% 0 0.0% 3 0.8% 4 1.1% Coronaviru s 229E 17 1.4% 2 1.0% 2 2.0% 2 1.2% 6 1.6% 5 1.4% Coronaviru s OC43 33 2.8% 9 4.4% 2 2.0% 5 2.9% 10 2.7% 7 2.0% Coronaviru s NL63 41 3.4% 10 4.9% 10 10.1% 10 5.8% 10 2.7% 1 0.3% Coronaviru s HKU1 7 0.6% 1 0.5% 0 0.0% 1 0.6% 3 0.8% 2 0.6% Rhinovirus/ Enterovirus 159 13.3% 39 19.0% 23 23.2% 24 13.9% 45 12.1% 28 8.0% Human Metapneu movirus 66 5.5% 19 9.3% 13 13.1% 11 6.4% 15 4.0% 8 2.3% Human Bocavirus 22 1.8% 13 6.3% 5 5.1% 1 0.6% 1 0.3% 2 0.6% C. pneumonia e 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% M. pneumonia e 6 0.5% 0 0.0% 0 0.0% 2 1.2% 4 1.1% 0 0.0% 1 Five (5) specimens generated Influenza A un-subtypeable result by NxTAG RPP (i.e. Influenza A matrix positive but H1 and H3 subtype negative). All 5 specimens were negative for Influenza A H1 and H3 by comparator. 69 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:

idK152386_s40000_e42000

K152386.txt

conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

.9% 1 0.7% Rhinovirus/ Enterovirus 195 20.9 % 76 30.6 % 57 37.7% 45 25.0 % 11 5.2% 6 4.2% Human Metapneu movirus 88 9.4% 34 13.7 % 21 13.9% 14 7.8% 9 4.2% 10 7.0% Human Bocavirus 28 3.0% 16 6.5% 10 6.6% 2 1.1% 0 0.0% 0 0.0% C. pneumonia e 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% M. pneumonia e 3 0.3% 0 0.0% 2 1.3% 1 0.6% 0 0.0% 0 0.0% 1One (1) specimen generated Influenza A un-subtypeable result by NxTAG RPP (i.e. Influenza A matrix positive but H1 and H3 subtype negative). This specimen was negative for Influenza A H1 and H3 by comparator. Two (2) Influenza A positive specimens generated both H1 and H3 positive calls by NxTAG RPP. 68 Table 72 - Expected Values for NxTAG RPP Clinical Samples (Jan 2015 – Mar 2015) Target (Analyte) Overall (n=1198) 0-1 year (n=205) >1-5 years (n=99) >5-21 years (n=173) >21-65 years (n=372) >65 years (n=349) No. EV No. EV No. EV No. EV No. EV No. EV Adenovirus 36 3.0% 7 3.4% 8 8.1% 6 3.5% 6 1.6% 9 2.6% Influenza A 2251 18.8% 9 4.4% 16 16.2% 40 23.1% 80 21.5% 80 22.9% Influenza A H1 3 0.3% 1 0.5% 0 0.0% 0 0.0% 2 0.5% 0 0.0% Influenza A H3 217 18.1% 8 3.9% 15 15.2% 39 22.5% 75 20.2% 80 22.9% Influenza B 49 4.1% 2 1.0% 3 3.0% 21 12.1% 13 3.5% 10 2.9% Respiratory Syncytial Virus A 69 5.8% 28 13.7% 8 8.1% 5 2.9% 12 3.2% 16 4.6% Respiratory Syncytial Virus B 64 5.3% 31 15.1% 8 8.1% 4 2.3% 9 2.4% 12 3.4% Parainfluen za 1 4 0.3% 1 0.5% 1 1.0% 0 0.0% 0 0.0% 2 0.6% Parainfluen za 2 2 0.2% 0 0.0% 0 0.0% 0 0.0% 1 0.3% 1 0.3% Parainfluen za 3 35 2.9% 17 8.3% 2 2.0% 1 0.6% 7 1.9% 8 2.3% Parainfluen za 4 10 0.8% 1 0.5% 2 2.0% 0 0.0% 3 0.8% 4 1.1% Coronaviru s 229E 17 1.4% 2 1.0% 2 2.0% 2 1.2% 6 1.6% 5 1.4% Coronaviru s OC43 33 2.8% 9 4.4% 2 2.0% 5 2.9% 10 2.7% 7 2.0% Coronaviru s NL63 41 3.4% 10 4.9% 10 10.1% 10 5.8% 10 2.7% 1 0.3% Coronaviru s HKU1 7 0.6% 1 0.5% 0 0.0% 1 0.6% 3 0.8% 2 0.6% Rhinovirus/ Enterovirus 159 13.3% 39 19.0% 23 23.2% 24 13.9% 45 12.1% 28 8.0% Human Metapneu movirus 66 5.5% 19 9.3% 13 13.1% 11 6.4% 15 4.0% 8 2.3% Human Bocavirus 22 1.8% 13 6.3% 5 5.1% 1 0.6% 1 0.3% 2 0.6% C. pneumonia e 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% M. pneumonia e 6 0.5% 0 0.0% 0 0.0% 2 1.2% 4 1.1% 0 0.0% 1 Five (5) specimens generated Influenza A un-subtypeable result by NxTAG RPP (i.e. Influenza A matrix positive but H1 and H3 subtype negative). All 5 specimens were negative for Influenza A H1 and H3 by comparator. 69 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:

idK170974_s0_e2000

K170974.txt

purpose for submission

New device

SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten- color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2 Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte- lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3 with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4 optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5 3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488- nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High Purpose for submission:

idK170974_s0_e2000

K170974.txt

type of test

Quantitative and Semi-quantitative Flow Cytometric Immunoassays

) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten- color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2 Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte- lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3 with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4 optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5 3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488- nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High Type of test: