i-STAT G CartridgeNAMEi-STAT G Cartridge – REF 03P83-25INTENDED USEThe test for glucose, as part of the i-STAT System, is intended for use in the invitro quantification of glucose in arterial, venous, or capillary whole blood.Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydratemetabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia,idiopathic hypoglycemia, and pancreatic islet cell carcinoma.SUMMARY AND EXPLANATION/CLINICAL SIGNIFICANCEMeasured:Glucose (Glu)Glucose is a primary energy source for the body and the only source of nutrients for brain tissue.Measurements for determination of blood glucose levels are important in the diagnosis and treatmentof patients suffering from diabetes and hypoglycemia. Some causes for increased values of glucoseinclude diabetes mellitus, pancreatitis, endocrine disorders (e.g., Cushing’s syndrome), drugs (e.g.,steroids, thyrotoxicosis), chronic renal failure, stress, or I.V. glucose infusion. Some causes ofdecreased values of glucose include insulinoma, adrenocortical insufficiency, hypopituitarism, massiveliver disease, ethanol ingestion, reactive hypoglycemia, and glycogen storage disease.TEST PRINCIPLEThe i-STAT System uses direct (undiluted) electrochemical methods. Values obtained by direct methodsmay differ from those obtained by indirect (diluted) methods. 1Measured:Glucose (Glu)Glucose is measured amperometrically. Oxidation of glucose, catalyzed by the enzyme glucoseoxidase, produces hydrogen peroxide (H2O2). The liberated H2O2 is oxidized at the electrode toproduce a current proportional to the sample glucose concentration.See below for information on factors affecting results. Certain substances, such as drugs, may affectanalyte levels in vivo. 2 If results appear inconsistent with the clinical assessment, the patient sampleshould be retested using another cartridge.REAGENTSContentsEach i-STAT cartridge contains one reference electrode (when potentiometric sensors are included inthe cartridge configuration), sensors for the measurement of specific analytes, and a buffered1Art: 765790-00 Rev. ARev. Date: 20-Feb-2020

aqueous calibrant solution that contains known concentrations of analytes and preservatives. A list ofreactive ingredients for the i-STAT G cartridge is shown below:SensorReactive IngredientGlucoseGlucose OxidaseGluBiological SourceN/AAspergillus nigerMinimum Quantity7 mmol/L0.002 IUWarnings and Precautions For in vitro diagnostic use.Cartridges are intended for single-use only. Do not reuse.Refer to the i-STAT 1 System Manual for all warnings and precautions.Storage Conditions Refrigerated at 2-8 C (35-46 F) until expiration date.Room Temperature at 18-30 C (64-86 F). Refer to the cartridge box for shelf life.INSTRUMENTSThe i-STAT G cartridge is intended for use with the i-STAT 1 analyzer.SPECIMEN COLLECTION AND PREPARATION FOR ANALYSISSpecimen TypesArterial, venous or capillary whole blood.Sample Volume: 65 µLBlood Collection Options and Test Timing (time from collection to cartridge coagulant3 minutesWith balancedheparinanticoagulant orlithium heparinanticoagulant(syringe must befilled permanufacturer'srecommendation) Remixthoroughlybefore fillingcartridge.30minutesWith lithiumheparinanticoagulant(tubes must befilled permanufacturer'srecommendation) Remixthoroughlybefore fillingcartridge,30 minutesCapillaryTestTubesTimingWith balanced 3 minutesheparinanticoagulantorlithium heparinif labeled for themeasurementof electrolytesPROCEDURE FOR CARTRIDGE TESTINGEach cartridge is sealed in a foil pouch for protection during storage--do not use if pouch has beenpunctured.o A cartridge should not be removed from its protective pouch until it is at room temperature(18-30 C or 64-86 F). For best results, the cartridge and analyzer should be at roomtemperature.Rev. Date: 20-Feb-2020Art: 765790-00 Rev. A2

ooooSince condensation on a cold cartridge may prevent proper contact with the analyzer, allowrefrigerated cartridges to equilibrate at room temperature for 5 minutes for a single cartridgeand 1 hour for an entire box before use.Use a cartridge immediately after removing it from its protective pouch. Prolonged exposuremay cause a cartridge to fail a Quality Check.Do not return unopened, previously refrigerated cartridges to the refrigerator.Cartridges may be stored at room temperature for the time frame indicated on the cartridgebox.Filling and Sealing the Cartridge (after cartridge has been equilibrated and blood sample has beencollected)1. Place the cartridge on a flat surface.2. Mix the sample thoroughly. Invert a lithium heparin blood collection tube at least 10 times. Ifsample was collected into a syringe, invert syringe for 5 seconds then roll the syringebetween the palms (hands parallel to the ground) for 5 seconds, flip and roll for an additional5 seconds. The blood in the hub of the syringe will not mix, therefore expelling 2 drops beforefilling a cartridge is desired. Note that it may be difficult to properly mix a sample in a 1.0 mLsyringe.3. Fill the cartridge immediately after mixing. Direct the hub of syringe or tip of the transferdevice (capillary tube, pipette, or dispensing tip) into the sample well of the cartridge.4. Slowly dispense sample into the sample well until the sample reaches the fill mark indicatedon the cartridge. Cartridge is properly filled when the sample reaches the ‘fill to’ mark and asmall amount of sample is in the sample well. The sample should be continuous, no bubblesor breaks (see System Manual for details).5. Fold the snap closure over the sample well.Performing Patient Analysis1. Press the power button to turn on the handheld.2. Press 2 for i-STAT Cartridge.3. Follow the handheld prompts.4. Scan the lot number on the cartridge pouch.5. Continue normal procedures for preparing the sample, and filling and sealing the cartridge.6. Push the sealed cartridge into the handheld port until it clicks into place. Wait for the test tocomplete.7. Review the results.For additional information for cartridge testing, refer to the i-STAT 1 System Manual located TimeApproximately 130–200 secondsQuality ControlThe i-STAT quality control regimen comprises four aspects, with a system design that reduces theopportunity for error, including:1. A series of automated, on-line quality measurements that monitors the sensors, fluidics, andinstrumentation each time a test is performed.2. A series of automated, on-line procedural checks that monitors the user each time a test isperformed.3. Liquid materials are available to be used to verify the performance of a batch of cartridgeswhen they are first received or when storage conditions are in question. The performance ofthis procedure is not a manufacturer’s system instruction.3Art: 765790-00 Rev. ARev. Date: 20-Feb-2020

4. Traditional quality control measurements that verify the instrumentation using an independentdevice, which simulates the characteristics of the electrochemical sensors in a way thatstresses the performance characteristics of the instrumentation.For additional information on Quality Control, refer to the i-STAT 1 System Manual located VerificationCalibration Verification is a procedure intended to verify the accuracy of results over the entiremeasurement range of a test. The performance of this procedure is not a manufacturer’s systeminstruction. However, it may be required by regulatory or accreditation bodies. While the CalibrationVerification Set contains five levels, verification of the measurement range could be accomplished usingthe lowest, highest and mid-levels.EXPECTED VALUESTESTREPORTABLERANGEUNITS *REFERENCERANGE 3(arterial)(venous)MEASUREDGlu*mmol/Lmg/dLg/L1.1 38.920 7000.20 7.003.9 5.870 1050.70 1.05The i-STAT System can be configured with the preferred units. (See “Unit Conversion” below.)Unit Conversion:o Glucose (Glu): To convert mg/dL to mmol/L, multiply the mg/dL value by 0.055.The i-STAT reference ranges for whole blood listed above are similar to reference ranges derivedfrom serum or plasma measurements with standard laboratory methods.The reference ranges programmed into the analyzer and shown above are intended to be used asguides for the interpretation of results. Since reference ranges may vary with demographic factors suchas age, gender and heritage, it is recommended that reference ranges be determined for the populationbeing tested.METROLOGICAL TRACEABILITYThe measured analyte in the i-STAT G cartridge is traceable to the following reference materials ormethods. The i-STAT System controls and calibration verification materials are validated for use onlywith the i-STAT System and assigned values may not be commutable with other methods.Glucose (Glu)The i‑STAT System test for glucose measures glucose amount-of-substance concentration in theplasma fraction of arterial, venous, or capillary whole blood (dimension mmol L‑1) for in vitro diagnosticuse. Glucose values assigned to i-STAT System controls and calibration verification materials aretraceable to the U.S. National Institute of Standards and Technology (NIST) standard reference materialSRM965.Additional information regarding metrological traceability is available from Abbott Point of Care Inc.PERFORMANCE CHARACTERISTICSThe typical performance data summarized below was collected in health care facilities by health careprofessionals trained in the use of the i-STAT System and comparative methods.Rev. Date: 20-Feb-2020Art: 765790-00 Rev. A4

PrecisionPrecision data was collected in multiple sites as follows: Duplicates of each control fluid were tested inthe morning and in the afternoon on five days for a total of 20 replicates. The averaged statistics arepresented below.TestGluAqueousControlLevel 1Level CV (%)[Coefficientof Variation (%)]1.60.8Method ComparisonMethod comparison data was collected using CLSI guideline EP9-A 4 .Deming regression analysis 5 was performed on the first replicate of each sample. In the methodcomparison table, n is the number of specimens in the data set, Sxx and Syy refer to estimates ofimprecision based on the duplicates of the comparative and the i-STAT methods respectively, Sy.x isthe standard error of the estimate, and r is the correlation coefficient.*Method comparisons will vary from site to site due to differences in sample handling, comparativemethod calibration and other site-specific variables.* The usual warning relating to the use of regression analysis is summarized here as a reminder. For any analyte,“if the data is collected over a narrow range, the estimate of the regression parameters are relatively imprecise andmay be biased. Therefore, predictions made from these estimates may be invalid” 5. The correlation coefficient, r,can be used as a guide to assess the adequacy of the comparative method range in overcoming this problem. Asa guide, the range of data can be considered adequate if r 0.975.Glucose/Glu(mg/dL)Venous blood samples were collectedin lithium heparin Vacutainer tubesand analyzed in duplicate on thei-STAT System.A portion of the specimen wascentrifuged and the plasma portionanalyzed in duplicate on comparativemethods within 20 minutes anCoulter LX20 Bayer 91.01-0.851.57482570.998FACTORS AFFECTING RESULTSThe following substances were evaluated in plasma for the Glucose analyte at the test concentrationsrecommended in CLSI guideline EP7-A2 6 unless otherwise noted. For those identified as an interferantthe interference is (mmol/L)0.045 71.32GluGluNoYes0.132 7GluNo2.010.2GluGluNoYes0.3 8 9GluNo0.34GluNoAnalyteInterference(Yes/No)Art: 765790-00 Rev. ACommentIncreased resultsDecreased results.Rev. Date: 20-Feb-2020

.5GluYesDecreased results. Use anothermethod.2.5 10 11 12GluYesDecreased 060.133 eNithiodote iocyanate(therapeutic)Uric Acid6.613.3GluGluNoNo16.7 14GluYesDecreased results0.314.346.9GluGluGluNoNoYesDecreased results7GluNoGluNo0.51.4Increased results. Use anothermethod.The degree of interference at concentrations other than those reported above might not be predictable.It is possible that interfering substances other than those tested may be encountered.Relevant comments regarding interference of Acetaminophen, Acetylcysteine, Bromide, Hydroxyurea,and Nithiodote are noted below:o Acetaminophen has been shown to interfere with glucose results in the i-STAT G cartridge, ata concentration prescribed by the CLSI guideline, 1.32 mmol/L, which represents a toxicconcentration of acetaminophen. Acetaminophen at 0.132 mmol/L, which represents the upperend of the therapeutic concentration, has been shown not to significantly interfere with i-STATglucose results for i-STAT G cartridge.o Acetylcysteine has been tested at two levels: the CLSI recommended level and a concentrationof 0.30 mmol/L. The latter is 3 times the peak plasma therapeutic concentration associated withtreatment to reverse acetaminophen poisoning. APOC has not identified a therapeutic conditionthat would lead to levels consistent with the CLSI recommended level. Acetylcysteine at aconcentration of 10.2 mmol/L decreased i-STAT glucose results, while acetylcysteine at aconcentration of 0.3 mmol/L did not significantly interfere with i-STAT glucose results.o Bromide has been tested at two levels: the CLSI recommended level and a therapeutic plasmaconcentration level of 2.5 mmol/L. The latter is the peak plasma concentration associated withhalothane anesthesia, in which bromide is released. APOC has not identified a therapeuticcondition that would lead to levels consistent with the CLSI recommended level. Bromide testedat concentrations of 2.5 and 37.5 mmol/L decreased i-STAT glucose results.o Hydroxyurea is a DNA synthesis inhibitor used in the treatment of various forms of cancer,sickle cell anemia, and HIV infection. This drug is used to treat malignancies includingmelanoma, metastatic ovarian cancer, and chronic myelogenous leukemia. It is also used inthe treatment of polycythemia vera, thrombocythemia, and psoriasis. At typical doses rangingfrom 500 mg to 2 g/day, concentrations of hydroxyurea in patients’ blood may be sustained atapproximately 100 to 500 μmol/L. Higher concentrations may be observed soon after dosing orat higher therapeutic doses.o Nithiodote (sodium thiosulfate) is indicated for the treatment of acute cyanide poisoning. Thejournal article titled “Falsely increased chloride and missed anion gap elevation duringtreatment with sodium thiosulfate” indicated that sodium thiosulfate could be used in thetreatment of calciphylaxis indicating that “the highest concentration likely to be seen in plasma[is] after infusion of a 12.5 g dose of sodium thiosulfate pentahydrate. Assuming that the 12.5g dose of sodium thiosulfate pentahydrate is distributed in a typical blood volume of 5 L with ahematocrit of 40%, the peak sodium thiosulfate plasma concentration expected is 16.7 mmol/L.”14Rev. Date: 20-Feb-2020Art: 765790-00 Rev. A6

OTHER FACTORS AFFECTING RESULTSFactorAnalyteEffectAllowing bloodto standGluGlucose values will decrease in whole blood samples over time. Venousblood glucose is as much as 7 mg/dL less than capillary blood glucoseas a result of tissue utilization. 15pH dependenceGluThe dependence of the i-STAT glucose with respect to pH is as follows:Values below 7.4 at 37 C decrease results by approximately 0.9 mg/dL(0.05 mmol/L) per 0.1 pH units. Values above 7.4 at 37 C increaseresults by approximately 0.8 mg/dL (0.04 mmol/L) per 0.1 pH units.PO2dependenceGluThe dependence of the i-STAT glucose with respect to PO2 is asfollows: Oxygen levels of less than 20 mmHg (2.66 kPa) at 37 C maydecrease results.7Art: 765790-00 Rev. ARev. Date: 20-Feb-2020

KEY TO SYMBOLSSymbolDefinition/Use14 days room temperature storage at 18–30 ⁰C.Use by or expiration date.The expiration date, expressed as YYYY-MM-DD, indicates the last day theproduct may be used.Manufacturer's lot number or batch code.The lot number or batch code appears adjacent to this symbol.Sufficient for n tests.Authorized representative for Regulatory Affairs in the European Community.Temperature limitations.The upper and lower limits for storage are adjacent to upper and lower arms.Catalog number, list number, or reference.Do not reuse.Manufacturer.Consult instructions for use or see System Manual for instructions.In vitro diagnostic medical device.Compliance to the European directive on in vitro diagnostic devices(98/79/EC)For prescription use only.Additional Information: To obtain additional product information and technical support, refer to thecompany website at Date: 20-Feb-2020Art: 765790-00 Rev. A8

References1. Tietz NW, Pruden EL, Siggaard-Andersen O. Electrolytes. In: C.A. Burtis andE.R. Ashwood, ed. Tietz Textbook of Clinical Chemistry. Second Edition ed.Philadelphia: W.B. Saunders Company; 1994.2. Young DS. Effects of Drugs on Clinical Laboratory Tests. 3rd ed. ed.Washington, DC: American Association of Clinical Chemistry; 1990.3. Painter PC, Cope JY, Smith JL. Reference Ranges, Table 41–20. In: C.A. Burtisand E.R. Ashwood, ed. Tietz Textbook of Clinical Chemistry. Second Edition ed.Philadelphia: W.B. Saunders Company; 1994.4. CLSI. Method Comparison and Bias Estimation Using Patient Samples;Approved Guideline. CLSI document EP9-A. 1995.5. Cornbleet PJ, Gochman N. Incorrect least-squares regression coefficients inmethod-comparison analysis. Clinical Chemistry. 1979;25(3).6. Clinical and Laboratory Standards Institute. Interference Testing in ClinicalChemistry; Approved Guideline—Second Edition. CLSI document EP7-A2.2005.7. Wu AHB. Tietz Clinical Guide to Laboratory Tests: Elsevier Health Sciences;2006.8. Whillier S, Raftos JE, Chapman B, Kuchel PW. Role of N-acetylcysteine andcystine in glutathione synthesis in human erythrocytes. Redox Report.2009;14(3):115-121.9. Ventura P, Panini R, Pasini MC, Scarpetta G, Salvioli G. N-acetyl-cysteinereduces homocysteine plasma levels after single intravenous administration byincreasing thiols urinary excretion. Pharmacological Research. 1999;40(4):345350.10. Hankins DC, Kharasch ED. Determination of the halothane metabolitestrifluoroacetic acid and bromide in plasma and urine by ion chromatography.Journal of Chromatography B: Biomedical Applications. May 1997;692(2):413418.11. Kharasch ED, Hankins D, Mautz D, Thummel KE. Identification of the enzymeresponsible for oxidative halothane metabolism: Implications for prevention ofhalothane hepatitis. Lancet. May 1996;347(9012):1367-1371.12. Morrison JE, Friesen RH. Elevated serum bromide concentrations followingrepeated halothane anaesthesia in a child. Canadian Journal of Anaesthesia.October 1990;37(7):801-803.13. Charles RA, Bee YM, Eng PHK, Goh SY. Point-of-care blood ketone testing:Screening for diabetic ketoacidosis at the emergency department. SingaporeMedical Journal. November 2007;48(11):986-989.14. Wendroth SM, Heady TN, Haverstick DM, et al. Falsely increased chloride andmissed anion gap elevation during treatment with sodium thiosulfate. ClinicaChimica Acta. April 2014;431:77-79.15. Young DS, Bermes EW. Influence of Site Collection on Blood Gases and pH. In:C.A. Burtis and E.R. Ashwood, ed. Tietz Textbook of Clinical