Source: https://www.fda.gov/medicaldevices/safety/emergencysituations/ucm161496.htm
Timestamp: 2019-04-21 06:10:08
Document Index: 166889128

Matched Legal Cases: ['§ 263', '§ 360', '§ 263', '§ 360', '§ 263', '§ 263', '§ 360']

Since February 26, 2016, when the Secretary of Health and Human Services (HHS) declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, FDA has issued an Emergency Use Authorization (EUA) for a number of molecular- and serological-based assays for Zika. In the case of the molecular-based assays, IVD developers as part of their EUA conditions are required to test an FDA Reference Material Panel that includes two different Zika virus strains from the Asian lineage (S1 and S2), using an FDA protocol that included a sensitivity evaluation. Depending on the sample type, the majority of the NAT assays have analytical sensitivities between 500 and 5000 Units/mL (or better) summarized in Table 1, along with some other performance characteristics determined during the EUA evaluation. In addition to sensitivity, the currently authorized tests offer unique characteristics with respect to sample throughput, testing environment, claimed sample types and performance, that are taken into account when considering whether to issue an EUA for an assay, summarized in Table 2. For more information about EUAs in the context of the Zika virus response, please visit FDA’s medical countermeasures website.
ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.)
On September 18, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Siemens Healthcare Diagnostics Incorporated's ADVIA Centaur Zika test for the presumptive qualitative detection of Zika virus IgM antibodies in human serum and plasma (potassium EDTA or lithium heparin, each collected alongside a patient-matched serum specimen) specimens collected from individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high or moderate complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after onset of symptoms or risk of exposure, respectively. Where there are presumptive Zika positive results from the ADVIA Centaur Zika test, confirmation of the presence of anti-Zika IgM antibodies requires additional testing, as described in the Scope of the Letter of Authorization (Section II) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
In response to Siemens Healthcare Diagnostic Inc.'s request, on November 16, 2017 FDA concurred with the update to the Instructions for Use for the ADVIA Centaur Zika test to improve the overall clarity, make some minor editorial modifications and to correct some typographical errors.
In response to Siemens Healthcare Diagnostic Inc.’s request, on April 18, 2019 FDA concurred with the request to modify the ADVIA Centaur Zika test to include surfactant in the ADVIA Centaur Zika IgM assay reagent buffers and the related updates of the Instructions for Use for the ADVIA Centaur Zika test to (1) include the new clinical and analytical data collected to support the modification granted in this letter, (2) include updated recommendations for specimen storage based on recent specimen stability studies, and (3) correct some minor typographical errors to improve the overall clarity. FDA also concurred with the update to the Instructions for Use for the (1) Zika Ab (ZikaAb) Quality Control, and (2) Zika IgM (ZikaM) Quality Control to include the 60-day open vial storage claim.
Letter Granting EUA Amendment(s) (November 16, 2017)
Letter Granting EUA Amendment(s) (April 18, 2019)
LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated)
On April 5, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of DiaSorin Incorporated's ("DiaSorin") LIAISON XL Zika Capture IgM Assay for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high or moderate complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Specimens used with the LIAISON XL Zika Capture IgM Assay should be collected between 8 days and 10 weeks after risk of exposure or onset of symptoms. Where there are presumptive Zika IgM positive and presumptive recent Zika positive results from the LIAISON XL Zika Capture IgM Assay, confirmation of the presence of anti-Zika IgM antibodies requires additional testing, as described in the Scope of Authorization of the authorization letter (Section II) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
In response to DiaSorin Incorporated's request, on November 6, 2017 FDA concurred with the update to the Instructions for Use for the LIAISON XL Zika Capture IgM Assay to: (1) improve the overall clarity of the procedural steps involved in the proper handling of the conjugates provided with the kit, (2) add a section on conditions of authorization for the laboratory to align with latest EUA requirements, and (3) include the 95% confidence interval for the negative percent agreement.
In response to DiaSorin Incorporated’s request, on December 27, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the LIAISON XL Zika Capture IgM assay to (1) replace the original ZIKV-M conjugate with an updated version of the reagent, (2) change the ZIKV-M calibrators from liquid to lyophilized form, (3) update the calibrator target values, (4) update the unopened kit shelf life stability claim, (5) update in-use stability claim for the ZIKV-M calibrators, (6) increase the number of vials included in the assay kit for each ZIKV-M calibrator to two to facilitate kit calibration over the existing 21 day reagent open-use stability claim, and (7) extend re-calibration frequency of the LIAISON XL Zika Capture IgM assay from 7 to 14 days. FDA also concurred with the related updates of the Instructions for Use and the Fact Sheets for the LIAISON XL Zika Capture IgM II that reflect the modifications described and DiaSorin’s request to modify the name from LIAISON XL Zika Capture IgM to LIAISON XL Zika Capture IgM II.
Letter Granting EUA Amendment(s) (November 6, 2017)
Letter Granting EUA Amendment(s) (December 27, 2018)
ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.)
On August 17, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of InBios International, Inc.'s ("InBios"), ZIKV Detect IgM Capture ELISA for the presumptive detection of Zika virus IgM antibodies in human sera collected from individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Where there are presumptive Zika positive, possible Zika positive, or presumptive other flavivirus positive results from the ZIKV Detect IgM Capture ELISA, confirmation of the presence of anti-Zika IgM antibodies or other flavivirus IgM antibodies requires additional testing, as described in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC guideline for the diagnosis of Zika virus infection.
In response to InBios International, Inc.'s request, on March 27, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the ZIKV Detect IgM Capture ELISA to improve the overall clarity of the procedural steps involved in the ZIKV Detect IgM Capture ELISA and to modify the Fact Sheets authorized with the ZIKV Detect IgM Capture ELISA to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016.
In response to InBios International, Inc.'s (InBios) request, on May 18, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the ZIKV Detect IgM Capture ELISA to (1) replace the original Ready-To-Use ZIKV Recombinant Antigen for IgM with an updated version of the reagent, (2) remove the use of horseradish peroxidase-labeled monoclonal anti-Flavivirus antibody (Conjugate for ZIKV IgM reagent) and replace with a secondary antibody targeting flavivirus antigens (Ready-To-Use Secondary Antibody reagent) and a horseradish peroxidase-labeled anti-mouse antibody (Conjugate for ZIKV IgM reagent) for the detection of human anti-ZIKV IgM, (3) update the ZIKV IgM Positive Control reagent, and (4) update the result interpretation. FDA also concurred with the related updates of the Instructions for Use and the Fact Sheets for the ZIKV Detect 2.0 IgM Capture ELISA that reflect the modifications described and InBios's request to modify the name from ZIKV Detect IgM Capture ELISA to ZIKV Detect 2.0 IgM Capture ELISA
Letter Granting EUA Amendment(s) (March 27, 2017)
Letter Granting EUA Amendment(s) (May 18, 2018)
xMAP MultiFLEX Zika RNA Assay (Luminex Corporation)
On August 4, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Luminex Corporation's xMAP MultiFLEX Zika RNA Assay for the qualitative detection of RNA from Zika virus in human serum, plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
In response to Luminex Corporation's request, on January 7, 2017, FDA concurred with the modifications to the authorized xMAP MultiFlex Zika RNA Assay Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016. The Instructions for Use remains unchanged by this request.
In response to Luminex's request, on May 19, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling and Fact Sheets for the xMAP MultiFLEX Zika RNA Assay to include some minor updates and clarifications requested by FDA.
Letter Granting EUA Amendment(s) (January 7, 2017)
Letter Granting EUA Amendment(s) (May 19, 2017)
OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.) - July 31, 2015 & March 4, 2016
OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.) - For Use with whole Blood - July 31, 2015
Please be advised: OraSure Technologies Inc. has issued a recall for the OraQuick Ebola Rapid Antigen Test lot number 6648965. Please visit the CDRH recalls database for more information.
On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in venipuncture whole blood or fingerstick whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection), by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). The test may also detect antigens from Sudan Ebola virus and Bundibugyo Ebola virus; however, it does not distinguish between these different Ebola virus species. The OraQuick Ebola Rapid Antigen Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than the use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The OraQuick Ebola Rapid Antigen Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing of individuals without signs and symptoms of Ebola infection.
In response to OraSure Technologies, Inc.’s request, on January 30, 2019 FDA concurred with the modifications to the authorized Instructions for Use labeling for the OraQuick Ebola Rapid Antigen Test for use with Whole Blood to include new data on (1) Clinical Performance, (2) Interference, (3) Cross Reactivity and (4) Reproducibility of the device and to modify minor wording in the intended use of the device.
OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.) - For Use with Cadaveric Oral Fluid - March 4, 2016
On March 4, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick Ebola Rapid Antigen Test for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals.
In response to OraSure Technologie's request on September 26, 2016, FDA concurred with the modification of the Manufacturer Instructions/Package Insert (Instructions for Use) of the OraQuick Ebola Rapid Antigen Test - For Use with Cadaveric Oral Fluid under the emergency use authorization issued on March 4, 2016. The Manufacturer Instructions/Package Insert has been updated to include additional performance data ((1) LoD with cadaveric oral fluid; (2) interference testing with oral fluid and (3) additional cross reactivity data) to comply with condition Q in the original Authorization Letter from March 4, 2016.
In response to OraSure Technologies, Inc.’s request, on February 1, 2019 FDA concurred with the modifications to the authorized Instructions for Use labeling for the OraQuick Ebola Rapid Antigen Test for use with Cadaveric Oral Fluid to include new data on (1) Clinical Performance, (2) Cross Reactivity and (3) Reproducibility of the device.
Fact Sheet for the Response Team
Fact Sheet for Relatives and Caregivers
On November 9, 2018, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Chembio Diagnostic Systems, Inc.’s DPP Ebola Antigen System for the presumptive detection of Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in human capillary (“fingerstick”) whole blood, EDTA venous whole blood, and EDTA plasma from individuals with signs and symptoms of Ebola virus disease (EVD) in conjunction with epidemiological risk factors (including geographic locations with high prevalence of EVD), by laboratories and facilities adequately equipped, trained and capable of such testing (including treatment centers and public health clinics), pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). The DPP Ebola Antigen System is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola virus. The DPP Ebola Antigen System is not intended for use for general EVD screening, such as airport screening or contact tracing of individuals without signs and symptoms of EVD.
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