Clinical Evaluation of i-STAT Analyzer for Glucose, Hematocrit and Sodium
Conditions: Analytical Performance of Sodium, Glucose and Hematocrit Assays by the i-STAT 500 (Alinity) Analyzer
Sponsor: Abbott Point of Care

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Clinical Evaluation of i-STAT 500® Analyzer for Glucose, Hematocrit and Sodium 
Abbott Point of Care (APOC) 
 
 
 
WARNING:   
 
FOR INVESTIGATIONAL USE ONLY. The performance characteristics of this 
product have not been established.  No clinical decision or patient notification should be 
made based on the results obtained with this product. 
 
Protocol No.:   
CS-2016-0003 
 
 
Version: 
6   
 
Date: 
October 04, 2016 
 
 
Rationale for amendment: Incorporates Scientific Changes 
 
Abbott Monitors: 
 
Linda Nguyen 
Principal Clinical Scientist 
Phone: +1 613-688-5949 x 2388 
Email: linda.nguyen@abbott.com 
Alternate Email: ApocClinicalAffairs@abbott.com 
  
   
Saba Butt 
Clinical Research Associate 
Phone: +1 613-688-5949 x 2470 
Email: saba.butt@abbott.com 
 
  
Address/Fax: 
Abbott Point of Care  
 
 
 
 
for all monitors  
185 Corkstown Road 
 
Ottawa, Ontario K2H 8V4 
 
Fax: (613) 688-5987 
 
 
 
Part or all of the information in this protocol may be unpublished material. Accordingly, 
this protocol is to be treated as confidential, and restricted to its intended use. If any 
portion of this unpublished material is desired for purposes of publication, authorization 
is to be obtained from Abbott Point of Care.  

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Revision 
Number 
Effective Date 
Reason for revision 
02 
21-March-2016 
Initial Release 
03 
05-May-2016 
Heparinized capillary tubes are required for the study.  
Revisions were made on pages 7, 12 and 13 to include 
“balanced heparin capillary tubes”. 
04 
30-Jun-2016 
Added sentence to reference that the i-STAT EC4+ 
cartridge also tests for potassium and hemoglobin. The 
results for potassium and hemoglobin will be collected for 
informational purposes only (page 6). 
Reference to potassium and hemoglobin results will be 
collected but used for informational purposes only and 
entered into the electronic case report forms by site 
personnel (page 15).  
 
05 
22-Jul-2016 
Clarified collection and test times for native and contrived 
whole blood samples. 
06 
04-Oct-2016 
Change 1 
Change: The number of specimens to be collected 
per site has been increased from approximately 40-
55 to approximately 100.  
Reason: To allow for collecting an 
increased number of samples and samples 
sourced by the clinical sites. 
Justification: To provide sufficient number 
of specimens to cover the range of 
concentrations required for the three study 
analytes. 
 
Change 2 
Change: Extended the duration of the study from 
10 weeks to 16 weeks. 
Reason: To ensure all samples needed per 
the study protocol are obtained and received 
and tested by the clinical sites. 
Justification: To allow for completion of 
all study related activities within the given 
timeframe of the study protocol.  

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Table of Contents  
 
I. 
Introduction ................................................................................................................... 5 
II. 
Objectives ...................................................................................................................... 5 
III. 
Study Design .................................................................................................................. 6 
A. Overview ................................................................................................................. 6 
B. Ethics ....................................................................................................................... 7 
C. General Schedule of Events ..................................................................................... 7 
D. Comparator Method ................................................................................................. 7 
IV. Operating Conditions ..................................................................................................... 8 
A. Material and Equipment .......................................................................................... 8 
1. Product Description ........................................................................................... 8 
2. Product Storage and Handling Requirements .................................................... 9 
3. Instructions for Use ........................................................................................... 9 
B. Environment ............................................................................................................ 9 
C. Personnel Requirements .......................................................................................... 9 
V. 
Product Accountability ................................................................................................ 10 
VI. Study Methods and Procedures ................................................................................... 10 
A. Specimen Handling and Accountability ................................................................ 10 
B. General Study Procedures ...................................................................................... 10 
1. General Procedures for Use of the i-STAT 500 Analyzer ............................... 10 
2. Calibration ....................................................................................................... 11 
3. Operator Proficiency ........................................................................................ 11 
4. Cartridge Quality Control ................................................................................ 11 
C. Testing Procedures ................................................................................................ 12 
1. Method Comparison for Capillary Specimens ................................................ 12 
VII. Methods for Data Collection and Documentation ....................................................... 15 
A. Data Collection ...................................................................................................... 15 
B. Case Report Forms ................................................................................................ 16 
VIII. Adverse Events ............................................................................................................ 16 
IX. Statistical Procedures ................................................................................................... 17 
A. General Information............................................................................................... 17 

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B. Statistical Analysis Description (Method Comparison) ........................................ 18 
1. Study Design .................................................................................................... 18 
2. Analysis Variables ........................................................................................... 18 
3. Sample Size ..................................................................................................... 18 
4. Statistical Analysis Method ............................................................................. 19 
5. Level of Significance ....................................................................................... 19 
6. Data Handling Convention .............................................................................. 19 
7. Outliers ............................................................................................................ 20 
X. 
Conduct of the Study ................................................................................................... 20 
A. Responsibilities for Conduct of the Study ............................................................. 20 
B. Withdrawal from Study ......................................................................................... 21 
C. Protocol Amendments ........................................................................................... 21 
D. Protocol Deviations ............................................................................................... 21 
E. Incident Reports ..................................................................................................... 22 
F. Discontinuation of the Study ................................................................................. 22 
G. Site File/Record Storage ........................................................................................ 22 
H. Site Data ................................................................................................................ 22 
I. Correspondence ..................................................................................................... 23 
XI. References ................................................................................................................... 23 
XII. Investigator’s Agreement ............................................................................................. 24 
 

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I.  Introduction 
The i-STAT® System is an in vitro diagnostic test system which uses a portable clinical 
analyzer and single-use cartridge to perform simultaneous quantitative determination of 
specific analytes in whole blood.  
The i-STAT 500 analyzer is intended to be used by trained medical professionals for a 
variety of in vitro diagnostic tests and test panels using i-STAT test cartridges. 
The i-STAT 500 is an updated version of the i-STAT 1 Wireless clinical analyzer. The 
Abbott monitor will provide the i-STAT 500 Quick Reference Guide, which contains 
the instructions for use of the new i-STAT 500 analyzer. 
The performance of the investigational i-STAT 500 analyzer will be evaluated based on 
results of method comparison testing, as described in this protocol. Tests for glucose, 
hematocrit and sodium will be used to perform the evaluation for capillary specimens. 
The test for glucose, as part of the i-STAT System, is intended for use in the in vitro 
quantification of glucose in arterial, venous, or capillary whole blood. Glucose 
measurements are used in the diagnosis, monitoring, and treatment of carbohydrate 
metabolism disorders including, but not limited to, diabetes mellitus, neonatal 
hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This 
protocol will focus on glucose testing for capillary specimens only. 
The test for hematocrit, as part of the i-STAT System, is intended for use in the in vitro 
quantification of packed red blood cell volume fraction in arterial, venous, or capillary 
whole blood. Hematocrit measurements can aid in the determination and monitoring of 
normal or abnormal total red cell volume status including, but not limited to, conditions 
such as anemia, erythrocytosis, and blood loss related to trauma and surgery. The 
i-STAT System provides a calculated hemoglobin result using the hematocrit result. 
This protocol will focus on hematocrit testing for capillary specimens only. 
The tests for sodium, as part of the i-STAT System, are intended for use in the in vitro 
quantitation of sodium in arterial, venous or capillary whole blood. Sodium 
measurements are used for monitoring electrolyte imbalances. This protocol will focus 
on sodium testing for capillary specimens only. 
This study will be conducted in compliance with this protocol, Good Clinical Practice 
(GCP) and the applicable regulatory requirements. 
 
II.  Objectives 
The objective of this study is to compare the performance of the i-STAT 500 
analyzer to the marketed i-STAT 1 Wireless analyzer in a Point-of-Care (POC) 

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setting. The evaluation will be performed using the i-STAT EC4+ cartridge to test 
glucose, hematocrit and sodium on capillary specimens. 
The i-STAT EC4+ cartridge also tests for potassium and hemoglobin. The results 
for potassium and hemoglobin will be collected for informational purposes only. 
 
 
III. Study Design 
 
A. Overview 
 
Protocol directed testing will be performed at a minimum of three (3) external US 
sites to evaluate the i-STAT 500 analyzer for performance compared to the 
marketed i-STAT 1 Wireless analyzer using clinical specimens. For this study, the 
i-STAT EC4+ cartridge will be used to evaluate the results reported for glucose, 
hematocrit, and sodium.  
 
 
 
Method Comparison  
 
Method comparison testing will be performed using prospectively collected native 
capillary specimens. This testing will be performed at a minimum of three (3) sites. 
Testing of approximately 120 native specimens will be performed in singlicate on 
both the i-STAT 500 analyzer and the i-STAT 1 Wireless analyzer. One (1) i-STAT 
500 analyzer and one (1) i-STAT 1 Wireless analyzer will be used for this testing. 
Sufficient subjects must be enrolled to meet a minimum of 120 eligible subjects for 
study analysis. Each site will collect and test approximately 100 specimens until 
sufficient capillary specimens are collected and tested for study analysis. A 
minimum of one (1) lot of i-STAT EC4+ cartridges will be used for this testing. 
Sufficient specimens for each analyte within their respective target ranges must be 
obtained to meet the minimum requirement of eligible specimens for study analysis. 
Requirements for the study are: 
 
Analyte 
Capillary 
Glucose 
120 
Hematocrit 
120 
Sodium 
120 
 
 

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B. Ethics 
Capillary specimens for use in this study will be prospectively collected with 
informed consent. Study subjects (or legally authorized representatives, if 
applicable) must confirm their willingness to participate in the study by signing and 
dating an Institutional Review Board (IRB) approved consent form prior to the 
collection of the specimens or other study-related information. 
The investigator will ensure that an IRB has approved the protocol and written 
informed consent (if needed) prior to subject participation in this clinical study. The 
approval letter must be signed by the IRB chairman or authorized representative 
prior to the start of this clinical study.  
Until the clinical study is completed, the Investigator will advise their IRB of the 
progress of this clinical study, per IRB requirements. Written approval must be 
obtained from the IRB annually (or more frequently if required by the IRB) to 
continue the clinical study, according to each institution’s IRB requirements. 
Further, any amendments to the protocol as well as associated informed consent 
form changes will be submitted to the IRB and written approval obtained prior to 
implementation, according to each institution’s IRB requirements. 
All reports transferred to and communications with Abbott which pertain to 
specimens in the study must identify each specimen by a study number to ensure 
subject confidentiality. 
 
C. General Schedule of Events 
 
Study testing personnel will be required to demonstrate acceptable performance with 
the i-STAT 1 Wireless analyzer and the i-STAT 500 prior to beginning study-
directed procedures. The Abbott monitor will observe testing of training material 
and confirm that the correct procedural steps were taken and that acceptable results 
were obtained.  
After successful completion of the training, testing personnel will complete the 
study-directed procedures as described in this protocol. 
Specimens will be identified using a study identification number (SID).  
Case Report Forms (CRF) will be utilized to document completion of the test 
procedures. The Abbott monitor will review the data and CRF to assure compliance 
to the study-directed procedures and to monitor the progress of the study. 
The study will take approximately 16 weeks to complete depending on the ability of 
the site to source specimens. 
D. Comparator Method 
For method comparison, the comparator testing will be performed using the i-STAT 

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1 Wireless analyzer. All specimens will be tested using the FDA cleared i-STAT 
EC4+ cartridge. Comparator testing will be performed at a minimum of 3 sites. 
Testing will be performed as instructed in the i-STAT 1 System Manual and 
instructions for use of the test cartridge. The i-STAT 1 Wireless analyzer and 
peripherals will be supplied by Abbott.  
The glucose, hematocrit and sodium results from the i-STAT 1 Wireless will be 
compared to the corresponding glucose, hematocrit and sodium results of the i-
STAT 500. 
 
IV.  Operating Conditions   
 
A. Material and Equipment 
 
1.  Product Description 
 
Products, supplies, and materials listed below will be supplied by Abbott 
Laboratories. 
The investigational products for use in this study are as follows: 
  i-STAT 500 analyzer, List No. 023065-01 
  Specific hardware for use with investigational product: 
o  i-STAT 500 Rechargeable Battery, List No. 027642-01 
o  i-STAT 500 Base Station, List No. 026159-01 
o  i-STAT 500 Electronic Simulator, List No. 040018-01 
o  i-STAT 500 Printer Kit, List No. 025913-01 
The marketed products for use in this study are as follows: 
  i-STAT 1 Wireless analyzer, List No. 03P75-01 
  Electronic simulator, List No. 06F11-01 
  i-STAT EC4+ cartridges, List No. 03P81-25 
   i-STAT TriControls  
o  Level 1, List No. 05P71-01  
o  Level 2, List No. 05P72-01 
o  Level 3, List No. 05P73-01 
  i-STAT Printer, List No. 04P74-04 
  i-STAT Printer paper 
  Lithium Batteries for the i-STAT 1 analyzer, List No.06F21-26 
Additional materials to be supplied by Abbott: 
   Capillary Tubes, Plain 
   Capillary Tubes, Balanced Heparin (150µL) 
  BD Microtainer Contact Activated Lancets, PN 366594 (Blade 1.5mm 
wide x 2.0mm deep)  

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   PDI Super Sani-Cloth Germicidal Disposable Wipes 
   CaviWipes Disinfecting Towelettes 
Materials to be supplied by the site: 
   Gauze 
   Sharps Container 
 
Expired material(s) must not be used. 
A description of the investigational product is presented in the i-STAT 500 
Quick Reference Guide. 
2.  Product Storage and Handling Requirements 
The i-STAT 500 analyzer and any other study materials and equipment provided 
by Abbott should be segregated and stored in a secured location.  
All commercially available products will be handled according to the 
manufacturer’s package insert instructions and product labeling. 
Secured storage of these supplies with appropriately restricted access is required. 
3.  Instructions for Use 
Testing on the i-STAT 500 for this study will follow the procedures in this 
clinical protocol and the i-STAT 500 Quick Reference Guide in conjunction 
with the i-STAT 1 System Manual for information that is common to both the 
i-STAT 1 Wireless and the i-STAT 500 analyzers.    
All versions of the i-STAT 500 Quick Reference Guide will be retained in the 
Abbott clinical study files. For this study, relevant sections of the i-STAT 1 
System Manual will be provided by the Abbott Monitor.  
 
B. Environment 
 
Testing personnel for this study will include testers that are representative of Point 
of Care End Users such as point of care coordinators, nurses, respiratory therapists, 
medical assistants or physicians.   
 
C. Personnel Requirements 
 
The investigator and all study staff will be trained on the clinical protocol. 
The investigator and all study staff involved in the prospective collection of 
specimens must have completed Collaborative IRB Training Initiative (CITI) in the 
protection of human research subjects and Good Clinical Practice training, or 
equivalent. 
 

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Personnel involved in execution of the i-STAT analyzer testing must be trained on 
or have documented experience operating and maintaining the i-STAT 500 analyzer 
and the i-STAT 1 Wireless analyzer. Each individual will also be trained on the i-
STAT 500 Quick Reference Guide and will be required to demonstrate their ability 
to use the investigational analyzer prior to beginning the Testing Procedures 
described in this protocol. 
 
 
V. Product Accountability 
 
The clinical testing sites must maintain records and accountability documentation of the 
receipt dates, lot numbers, quantities, and the use, destruction and/or return of all 
investigational products. The Abbott monitor will periodically verify the accuracy of 
these inventories.  
All investigational products must be returned to Abbott or disposed of on-site. An 
investigator will not supply investigational products to any individual who is not named 
as a study investigator. 
 
 
  
 
 
VI.  Study Methods and Procedures 
 
A. Specimen Handling and Accountability 
 
Specimens must be processed according to the requirements defined in this protocol and 
instructions provided by the Abbott monitor. Refer to the i-STAT 1 Manual for 
instructions on the procedures for collection and testing of capillary whole blood 
specimens. 
A specimen may be withdrawn from the study if the sample is found unacceptable for 
testing (e.g. inappropriate handling prior to testing, inadequate volume), or for other 
assignable causes. The reason for removal must be documented. The Abbott monitor 
must be notified if a specimen is being considered for withdrawal. Specimens 
withdrawn from the study may need to be replaced, if deemed necessary by the Abbott 
monitor, to meet requirements for the minimum number of specimens. 
 
B. General Study Procedures 
 
1.  
General Procedures for Use of the i-STAT 500 Analyzer 
  Refer to the i-STAT 500 Quick Reference Guide for instructions on the use 
of the analyzer. 
  Refer to the i-STAT 500 Quick Reference Guide for instructions on cleaning 
and disinfecting the analyzer. 

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  An Electronic Simulator test should be completed for each i-STAT 500 
analyzer received. This should be performed prior to study directed testing. 
The successful completion of the Electronic Simulator check must be 
documented in the CRF. 
  If a test result is flagged (i.e. *** or < >) or a quality check code is displayed 
during study-directed testing, the data tape should be printed for all tests and 
the data entered into the appropriate eCRF. For quality check codes, 
complete an Incident CRF and document the action taken. 
2.  Calibration 
 
Calibration curves are standardized during manufacturing and adjustments, if 
required, are made during regular software updates. No operator intervention is 
needed. 
 
3.  Operator Proficiency 
 
Training materials (e.g., training panel and/or test controls) will be used to 
assess investigational analyzer proficiency. Analyzer proficiency with both 
i-STAT 500 and i-STAT 1 Wireless is to be performed by each user. Proficiency 
testing details will be provided by Abbott. The Abbott monitor will evaluate the 
results for acceptability. The results of the proficiency testing will be 
documented in the study files. 
 
4.  Cartridge Quality Control 
 
A temperature monitoring check must be performed for acceptance of the 
received cartridges.  Check the temperature indicator strip included in the 
shipping container. If the 3rd and 4th windows on the strip are colored, the 
cartridges should not be used and the Abbott monitor should be contacted. 
Complete the shipping and receipt information on the strip card. 
The i-STAT TriControls Level 1, 2 and 3 are to be tested on the i-STAT 1 
Wireless for each new shipment of cartridges received. The results obtained 
should be within the expected values in the Value Assignment Sheet. If a quality 
check code is generated or any result is out of range, repeat the control testing 
with a fresh ampule. If a second quality check code is generated or the result is 
still outside the expected range, contact the Abbott monitor. An incident CRF 
should be completed, documenting the action taken. Data tapes for all tests 
should be printed and entered into the appropriate eCRF. 
 
 
 

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C. Testing Procedures  
 
1. Method Comparison for Capillary Specimens 
 
a)  
Specimen Selection 
 
i) Study Population/Sample Size 
 
The site will source capillary specimens by prospective collection with 
informed consent. 
For glucose a minimum of 120 capillary specimens that span the 
measuring interval of glucose will be tested. Each site will source 
approximately 100 specimens until sufficient capillary specimens are 
collected and tested.  
For hematocrit a minimum of 120 capillary specimens that span the 
measuring interval of hematocrit will be tested. Each site will source 
approximately 100 specimens until sufficient capillary specimens are 
collected and tested.  
For sodium a minimum of 120 capillary specimens that span the 
measuring interval of sodium will be tested. Each site will source 
approximately 100 specimens until sufficient capillary specimens are 
collected and tested.  
Sites should attempt to source capillary specimens from all target levels. 
If all target levels cannot be sourced from native specimens, specimens 
may be contrived. An Abbott representative will assist with contriving 
specimens in accordance to an Abbott representative procedure that will 
be included in the study files. 
Should a contrived sample not meet the expected target concentration 
after contriving, the subject may be withdrawn from the study, ensuring to 
document the reason for withdrawal. 
A suggested distribution of capillary specimen target levels for glucose, 
hematocrit and sodium by site is presented in the chart below. 
 
 

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ii) Subject Inclusion and Exclusion Criteria 
 
Prospectively collected specimens should be from unique individuals. 
 
Inclusion Criteria 
 
 Subject is ≥ 18 years of age 
 Subjects (or their legal representative) who are willing to 
voluntarily consent to the study 
 
Exclusion Criteria 
 
 There are no exclusion criteria 
 
iii) Specimen Collection 
 
To obtain native capillary specimens, skin punctures will be performed on 
two fingers. The first skin puncture will be used to fill a balanced heparin 
capillary tube and transfer the sample to the i-STAT 1 Wireless analyzer. 
The second skin puncture will be used to fill a balanced heparin capillary 
tube and transfer the sample to the i-STAT 500 analyzer. 
A minimum of 150 µL of whole blood per individual capillary tube 
specimen is required to complete testing.  
If insufficient volume of whole blood is obtained in order to test on both 
the i-STAT 1 Wireless and i-STAT 500 analyzer, the subject may be 
asked to return for a repeat collection. To be eligible for participation in 
this study the same subject must have signed and dated an informed 
Glucose 
(mg/dL) 
~ # 
Sample/Site 
Hct 
(%PCV) 
~ #  
Sample/Site 
Na 
(mmol/L) 
~ # 
Sample/Site 
≤ 50 
2 
<27 
6 
≤ 130 
8 
> 50-80 
4 
27 – 35 
10 
131-140 
16 
> 80-120 
8 
36 – 50 
20 
141-150 
12 
> 120-200 
12 
>50 
4 
>150 
4 
> 200-300 
6 
Total 
40 
Total 
40 
> 300-400 
4 
> 400-500 
2 
>500 
2 
Total 
40 

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consent form for allowance of up to 4 skin punctures, prior to prospective 
collection of a whole blood specimen. 
For specimens that will be contrived, a maximum of 3 mL of venous 
blood specimen and/or a minimum of 250 µL capillary blood is required 
to complete method comparison testing.  
Each specimen will be given a unique study identification number (SID). 
The date and time of collection, the specimen type (native or contrived), 
and collection device (capillary), as applicable will be documented. 
 
b)  
Procedure 
Capillary specimen method comparison will be performed at a minimum of 3 
sites. Specimens will be tested on one (1) i-STAT 500 analyzer and one (1) i-
STAT 1 Wireless analyzer.  A minimum of one lot of i-STAT EC4+ cartridges 
per site will be used for this testing. 
Per the i-STAT 500 Quick Reference Guide, the Study Workflow and the i-
STAT 1 System Manual, collect specimen and perform testing in the Patient 
pathway on the i-STAT 500 menu.  
 
1.  Ensure at least two (2) i-STAT EC4+ cartridges are at room temperature.  
2. Prepare one i-STAT 500 analyzer and one i-STAT 1 Wireless Analyzer. 
3.  Collect specimen. If required, contrive the specimen per Abbott Instructions. 
Note: Testing for native or contrived whole blood specimens collected in 
balanced heparin capillary tubes must be within 3 minutes of collection. Test 
time is defined as the difference between sample collection time and the time 
when the cartridge is inserted into the device. Collection time is defined as 
the time when a sufficient volume of capillary sample is obtained.  
Note: A separate capillary tube must be used for each cartridge fill. 
4. Fill and Test Cartridges: 
a)  Place the first cartridge on a flat surface or hold it in a horizontal position. 
b)  Direct the tip of the capillary into the sample well. 
c)  Dispense sample slowly and steadily until it reaches the fill mark 
indicated on the cartridge label. Leave some sample in the sample well. 
d)  Fold the snap closure over the sample well. 

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e)  Press the rounded end of the closure until it snaps into place. Slightly lift 
finger or thumb and ensure that the cartridge is closed before completely 
removing finger or thumb from the closure. 
f)  Insert the cartridges into the i-STAT 1 Wireless analyzer before 
proceeding to the next cartridge. 
g)  Using a new capillary tube, repeat steps 3- 4 and 4a-4e for the second i-
STAT EC4+ cartridge (using a capillary specimen from the second 
fingerstick). Place the cartridge into the i-STAT 500 analyzer. 
After the results are displayed, remove and discard the cartridges. 
Print the results and tape them to the appropriate study form. 
If a test result is flagged with *** or a quality check code is displayed, a repeat 
of the testing procedure on both the i-STAT 1 Wireless and the i-STAT 500 
analyzer may be performed with new cartridges from the same subject. The 
subject must be eligible for repeat participation as per agreement in the signed 
and dated an informed consent form prior to prospective collection of a whole 
blood specimen. If the result is suppressed again, contact the Abbott monitor. 
The code that identifies the problem should be recorded on the Incident CRF. 
 
VII. Methods for Data Collection and Documentation 
 
A. Data Collection 
 
All results (numerical or flagged) will be printed from the i-STAT 500 and the 
i-STAT 1 Wireless analyzer to a portable printer.  Refer to the i-STAT 500 Quick 
Reference Guide and the i-STAT 1 System Manual for printing instructions. Results 
will be printed on thermal paper and labeled for Investigational Use Only. Data 
printed on thermal paper must be photocopied or captured via electronic storage 
media (e.g. electronic systems such as tablets). If photocopied, the original and 
photocopy of the analyzer printouts are to remain with the site’s study files.  A 
second copy of the printouts should be made and to be sent to the Abbott monitor as 
they are completed. If captured via electronic storage, the original data tape may be 
either be stored in the site’s study file or sent to the Abbott monitor. 
All i-STAT results will be entered into electronic case report forms by site 
personnel. If any i-STAT results cannot be entered into the case report form, the data 
will be manually entered into the database at Abbott using the analyzer printout. 
Potassium and hemoglobin results will be collected and entered into the electronic 
case report forms by site personnel. These results will be used by Abbott for 
informational purposes only. 
 

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B. Case Report Forms 
CRF for collection of data will be supplied by Abbott including detailed instructions 
for completion of these forms.   
CRF data or information related to the study will be recorded electronically using a 
web based system. Photo images of source data will be attached to the electronic 
CRF. Site personnel responsible for entering data will be trained on the use of the 
electronic system (i.e., access, entry and submission of data, photo file attachments). 
Data entered by the site will be reviewed by an Abbott monitor, and queried if 
needed. Queries should be resolved in a timely manner. 
Data or information recorded on the CRF with no prior written or electronic record, 
(e.g., specimen processing, storage date and time) will be considered the source 
document.  
The investigator must sign the CRF where indicated. The investigator’s signature 
indicates that the data are accurate and complete. Where signatures are required they 
must be handwritten or captured electronically per 21 CFR Part 11. Stamps for 
signatures are not allowed. 
At the conclusion of the study, a copy of the completed CRF will be maintained at 
each investigational site and a backup copy stored at Abbott. 
 
VIII. Adverse Events 
 
A Subject Adverse Event is any unfavorable or unintended medical occurrence (e.g., 
sign, symptom, or disease) temporally associated with the specimen collection 
procedure performed.  
A Subject Serious Adverse Event is an untoward medical occurrence that: 
  results in death 
  is life-threatening 
  requires inpatient hospitalization or prolongation of existing hospitalization 
  results in persistent or significant disability/incapacity, or 
  results in a congenital anomaly/birth defect. 
A Device Adverse Event is any effect on the health or safety of an individual 
associated with the use of a product that has or may have caused or contributed to an 
injury, a system malfunction or user error resulting in personal injury (e.g., electrical 
shocks, burns, etc.), or exposure to potentially hazardous material (e.g., chemical or 
biohazardous), or a fire or visible smoke that was not self-contained to the system and 
caused damage outside of the system. 

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A Device Serious Adverse Event is an adverse event that has or may have caused or 
contributed to a death or serious injury of an individual or an adverse event resulting 
from malfunction that could cause or contribute to a death or serious injury if the 
malfunction were to recur. A serious injury includes a life-threatening illness or injury, 
an illness or injury, which results in permanent impairment of a body function or 
permanent, irreversible damage to body structure, or a condition, an injury or illness 
necessitating a medical or surgical intervention by a health care professional to prevent 
permanent, irreversible impairment of a body function, or damage to a body structure. 
It is expected that drawing blood may cause pain, bruising, lightheadedness, and on rare 
occasion, infection at the site of the blood draw. These events will not be recorded as 
adverse events as they are considered to be normal events that may occur during the 
course of a blood draw. Other events that may occur such as fainting, that are not 
routinely associated with a blood draw, must be recorded on the Subject Adverse Event 
case report form and be followed to a satisfactory resolution. 
In the unexpected event of an adverse event or a serious adverse event resulting from 
use of the investigational device, the Abbott monitor must be notified immediately by 
telephone and subsequently in writing within five (5) days of the occurrence. These 
adverse events must be described on the Device Adverse Event case report form. All 
adverse events are to be followed to satisfactory resolution, and any measures taken, as 
well as the follow-up, reported on the appropriate case report form. 
 
IX.  Statistical Procedures 
A. General Information 
All data analyses will be performed, and tables and listings of data will be provided 
by APOC using validated statistical software.  
Additional subgroups of some testing sites and/or sample types may be created and 
analyzed.  
If revised or additional analyses are required, a description of the additional or 
revised analyses and justifications for the changes will be documented and approved 
by the same functional areas as the original approvers to the protocol. This 
documentation will be included in the clinical study files. 
The Abbott monitor will review all test results and may request that certain 
observations be deleted from analysis if there is an assignable cause, i.e., control or 
validity criteria failure, instrument errors or problems, acknowledged technologist 
error, and/or noncompliance with the study protocol. All results tested according to 
the protocol and not deleted will be eligible for analysis. 
The statistical analysis output along with a listing containing each observation 
collected for this study will be completed. The listing will be printed for data 

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included in the analysis and excluded from the analysis. The excluded listing will 
include the reasons for exclusion.  
It is expected that specimen collection will be completed at different times for each 
of the three assays (sodium, glucose and hematocrit) during the study. The data for a 
given assay may be analyzed against acceptance criteria once the specimen 
collection for that assay has been completed and may be used for different 
regulatory submissions (i.e. FDA response or 510(k) submission). Once specimen 
collection is determined to be completed, additional specimens will not be collected 
for that assay unless requested by a regulatory agency.  
Interim data for a given assay (before specimen collection is completed) will not be 
evaluated against acceptance criteria. Interim data monitoring will be conducted to 
ensure the data meets validity criteria and minimum sample size requirements. 
 
B. Statistical Analysis Description (Method Comparison) 
 
1. Study Design 
 
Method comparison testing will be performed using whole blood capillary 
specimens prospectively collected from routine patient care. This testing will 
be performed at a minimum of 3 sites. For each assay (glucose, hematocrit 
and sodium), testing of approximately 120 native and altered specimens will 
be performed in singlicate on both the i STAT 500 analyzer and the i STAT 
1 Wireless analyzer. One (1) i-STAT 500 and one (1) i-STAT 1 Wireless 
analyzer will be used for this testing. Each site should collect and test 
approximately 100 specimens until sufficient specimens are collected and 
tested for study analysis. A minimum of one lot of i STAT EC4+ cartridges 
will be used for this testing. 
 
2. Analysis Variables 
The analysis variable for the method comparison study is the i-STAT EC4+ 
cartridge glucose concentration values (mg/dL), hematocrit values (%PCV 
and sodium concentration values (mmol/L). 
 
 
3. Sample Size 
The sample size is based on the recommendation of CLSI EP09-A3.  
A minimum of 120 capillary whole blood specimens covering the measuring 
interval will be collected from a minimum of 3 sites. Each site should collect 
a minimum of 40 specimens. 
 
 

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Minimum of 3 sites 
Within each site: 
Number of lots = 1 
i-STAT 1 Wireless analyzers = 1 
i-STAT 500 analyzers = 1 
Replicates per specimen = 1 
 
 
4. Statistical Analysis Method 
Perform the following analyses for glucose, hematocrit and sodium 
separately: 
Analyses will be performed separately for each site and all sites combined. 
Deming and Passing-Bablok linear regression analysis will be performed 
using the single replicate of the i-STAT 500 results versus the single 
replicate of the i-STAT 1 Wireless results. The slope, intercept, correlation 
coefficient and 95% confidence intervals for these values will be reported. 
Scatter plots and Bland-Altman plots will be constructed as recommended in 
CLSI EP09-A3. 
The predicted bias (difference) between the i-STAT 500 result and the i-
STAT 1 Wireless result at the medical decision points and their 95% CIs 
will be calculated. 
 
5. Level of Significance 
 
Two-sided confidence intervals will be calculated at a 95% confidence level. 
 
6. Data Handling Convention 
 
All results from this testing that are performed according to the protocol and 
not excluded by the reviewers will be eligible for analysis. Reasons for any 
excluded results will be captured in the study database.  
  Exclude the specimen from analysis if no results can be obtained from 
either the i-STAT 1 Wireless or the i-STAT 500. 
  Exclude test results if there is an assignable cause. 
  Exclude the specimen if the analyte value of interest (e.g., glucose, 
hematocrit or sodium) is outside of the measuring interval on either 
analyzer. 

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 Exclude a result obtained from a subject that is for a bucket of a given 
analyte that is already filled with the reason “Not part of analysis.” 
 
7. Outliers 
 
The outlier criteria are based on CLSI document EP09-A3 Appendix B. 
The generalized Extreme Studentized Deviate (ESD) technique will be 
used to detect outliers. 
 
 
X.  Conduct of the Study 
 
 
A. Responsibilities for Conduct of the Study 
 
 
1) The investigator will have written and dated approval/favorable opinion from 
the Institutional Review Board (IRB) for the protocol and other documents as 
specified by the IRB before initiating the study. In some cases, the IRB may 
provide an expedited or exception review. 
2) The investigator is responsible for reporting to the IRB and obtaining the 
necessary approvals from his/her site administration. 
3) Abbott Laboratories will not initiate the study until the required pre-study 
documents are received from the site. Pre-study documents are aligned with 
GCP requirements and a detailed listing of the required pre-study documents 
will be provided to the investigator by the Abbott monitor. 
4) The investigator will perform the study in accordance with GCP. The Abbott 
monitor will provide the investigator with the GCP-aligned list of investigator 
requirements. 
5) The Abbott monitor will provide the investigator with the Guidance for Industry 
Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of 
Study Subjects (October 2009) for reference. 
6) Abbott Laboratories has a responsibility under GCP to monitor this clinical 
study. The Abbott monitor will provide the investigator with the GCP-aligned 
list of responsibilities of the Abbott monitor. 
7) The investigator will maintain a list of appropriately qualified persons to whom 
he/she has delegated significant study-related duties. This list must be updated as 
needed and the Abbott monitor must be notified of the changes.   
8) The investigator will assure that all subjects are provided both written and oral 
informed consents, and that the subject’s consent is documented in accordance 

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with local laws. In addition, every subject will be provided a copy of the consent 
form.  
9) The investigator will maintain the subject’s original consent form in the 
subject’s permanent medical record or in the investigator’s records, depending 
on site policy. 
10) The investigator agrees to the requirement for guaranteed access to source data 
and to the investigator himself/herself by the IRB, Abbott monitor(s), auditors, 
and regulatory inspectors for the purpose of data verification or correction. 
 
B. Withdrawal from Study 
 
A subject’s participation in this clinical study is voluntary and subject has the right 
to withdraw from the study any time without prejudice, however, the request to 
withdraw agreement does not include information that has already been made 
known or information gathered as a result of participation in the study.   
If a subject fails to meet the inclusion/exclusion criteria or if the protocol required 
specimen is not obtained, the subject must be withdrawn from the study.  All 
subjects enrolled in the study must be accounted for and the withdrawal of any 
subjects from the study will be documented on the appropriate CRF.   
If another specimen can be redrawn that meets the specimen collection 
requirements, the specimen may be recollected from the subject.  Alternatively, 
another subject may be enrolled into the study that meets the subject enrollment 
criteria.  
All subjects enrolled in the study must be accounted for and the withdrawal of any 
subjects from the study will be documented on the appropriate CRF.   
 
C. Protocol Amendments 
 
All protocol amendments will be written and approved by Abbott Laboratories prior 
to its submission for IRB review and approval or exemption. 
 
D. Protocol Deviations 
 
A protocol deviation is defined as a planned or unplanned departure from the study 
protocol. All protocol deviations that occur during this study will be recorded on the 
protocol deviation CRF. 
The investigator will not implement or deviate from the protocol without agreement 
from Abbott Laboratories and prior review and approval from the IRB. Exceptions 
to this include instances where it is necessary to eliminate an immediate hazard to 

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study subjects, or when the protocol changes involve only logistical or 
administrative aspects of the study. 
Planned deviations from this protocol must be reported to the monitor prior to 
implementation. The implemented deviation and the circumstances regarding the 
deviation will be documented on the protocol deviation CRF. The monitor will 
approve in writing the inclusion of any specimen, which does not meet all of the 
inclusion or exclusion criteria of the study. The monitor may provide verbal 
approval prior to the written response.  
 
E. Incident Reports 
 
An incident CRF will be used to document any incident(s) that occur during the 
clinical study. An incident is defined as any unplanned or unexpected event that 
occurs with or without the input or intervention of the operator. The incident CRF 
should include a description of the incident, possible cause (if known), action taken, 
and identify any specimens that were affected. 
 
F. Discontinuation of the Study 
 
The study may be terminated prior to the stated time for reasons of safety or 
efficacy, or for other identified causes. The reason for discontinuation will be 
documented in the clinical study master file. 
 
G. Site File/Record Storage 
 
The investigator should arrange for the retention of all study documents in the site 
file. The investigator shall retain the site file records for at least a period of 2 years 
following the date a marketing application is approved; or if no application is to be 
filed or if the application is not approved for such an indication, until at least 2 years 
after the investigation is discontinued and the FDA is notified. These documents 
should be retained for a longer period, however, if required by the applicable 
regulatory requirements or by agreement with the sponsor. It is the responsibility of 
the sponsor to inform the investigator/institution when these documents no longer 
need to be retained. 
 
H. Site Data 
 
At the completion of the study a listing of the site’s data generated during the study 
will be provided to each site. 

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I.  Correspondence  
All correspondence between the Abbott monitor and the testing site must be 
documented and retained as part of the study records (i.e. any telephone 
communication with the Abbott monitor should be documented in a telephone log; 
copies of e-mail messages should be printed). 
 
XI. References 
 
i-STAT 1 System Manual 
CDRH guidance document.  Guidance on Informed Consent for in Vitro Diagnostic 
Analyzer Studies Using Leftover Human Specimens that are Not Individually 
Identifiable, April 25, 2006. 
Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias 
Estimation Using Patient Samples; Approved Guideline – Third Edition, CLSI 
document EP09-A3 (ISBN 1-56238-887-8 [Print]; ISBN 1-56238-888-6[Electronic]). 
Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, 
Pennsylvania, 19087, USA, 2013. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
i-STAT is a registered trademark of the Abbott Group of Companies in various 
jurisdictions. 
 
 

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XII. 
Investigator’s Agreement 
By signing this statement the investigator agrees: 
1. I have read and understand the contents of the clinical study protocol entitled 
Clinical Evaluation of i-STAT 500® Clinical Analyzer for Glucose, 
Hematocrit, and Sodium (Protocol No. CS-2016-0003 Version 6 dated 
October 04, 2016) and the i-STAT 500 Quick Reference Guide and will 
adhere to the study requirements as presented, and applicable local 
regulations. 
2.   I will protect the rights, safety, and well-being of subjects. Before initiating 
the study and where required by local regulations, an Institutional Review 
Board (IRB) will review and approve the study protocol and all other 
applicable study material. A copy of the approval of the study protocol will 
be submitted to Abbott Laboratories. 
3. I will not use the results from products labeled as “For Investigational Use 
Only” for diagnostic purposes, because the performance characteristics of the 
product have not been established. 
4. I understand that Abbott Laboratories, its designees, and regulatory 
authorities may require access to source documents for verification of study 
data. 
5. I understand that if any questions arise, now or during the clinical evaluation, 
I will promptly contact the Abbott monitor or designee at Abbott 
Laboratories for clarification. 
 
Investigator (Printed Name):  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Title:   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Signature:   
 
 
 
 
 
 
 
 
 
Date:   
 
 
 
Institution Name:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Institution Address:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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