i-STAT G cartridge with the i-STAT 1 System
Device Facts
| Record ID | K223755 |
|---|---|
| Device Name | i-STAT G cartridge with the i-STAT 1 System |
| Applicant | Abbott Point of Care, Inc. |
| Product Code | CGA · Clinical Chemistry |
| Decision Date | Sep 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The i-STAT G cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose in arterial, venous or capillary whole blood in point of care or clinical laboratory settings. 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.
Device Story
The i-STAT G cartridge is a single-use, disposable test cartridge used with the i-STAT 1 handheld analyzer. It accepts 2-3 drops of whole blood (arterial, venous, or capillary) via a transfer device. The cartridge contains sensors, a fluid pack, and channels for controlled fluid movement. The analyzer moves the sample across the sensors to perform an amperometric measurement of oxidized hydrogen peroxide produced by glucose oxidase activity. Results are generated in approximately 2 minutes. Used in point-of-care or clinical laboratory settings by trained medical professionals. The output provides quantitative glucose levels to assist clinicians in diagnosing and managing metabolic disorders. The device benefits patients by providing rapid, actionable diagnostic information at the point of care.
Clinical Evidence
Bench testing only. Precision studies (internal and multi-site) evaluated repeatability and reproducibility across 5 concentration levels, showing within-lab CVs < 2.2%. Linearity was confirmed across 20-700 mg/dL (R²=0.999). Interference testing established limits for exogenous/endogenous substances. Method comparison (n=164 venous, n=173 arterial, n=234 capillary) against predicate and epoc systems showed high correlation (r=1.00 for all) and slope/intercept values near 1.0/0.0, respectively. No clinical trials were required.
Technological Characteristics
Handheld in vitro diagnostic system. Amperometric biosensor technology using glucose oxidase. Single-use disposable cartridge containing fluid pack, sensors, and waste chamber. Supports arterial, venous, and capillary whole blood. Connectivity via i-STAT 1 analyzer accessories (Downloader/Recharger). Calibration is 1-point on-board. Operates at room temperature or refrigerated storage.
Indications for Use
Indicated for patients requiring glucose quantification in arterial, venous, or capillary whole blood for diagnosis, monitoring, and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
Reference Devices
- epoc Blood Analysis System
Related Devices
- K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System · Abbott Point of Care, Inc. · Jul 28, 2023
- K163271 — i-Stat Alinity System with i-Stat Glucose test · Abbott Point of Care, Inc. · Apr 10, 2017
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K223755
B Applicant
Abbott Point of Care Inc.
C Proprietary and Established Names
i-STAT G cartridge with the i-STAT 1 System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CGA | 21 CFR 862.1345 | Glucose Test System | CH – Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modified device
B Measurand:
Glucose
C Type of Test:
Quantitative amperometric
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The i-STAT G cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose in arterial, venous or capillary whole blood in point of care or clinical laboratory settings.
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.
C Special Conditions for Use Statement(s):
Rx – For Prescription Use Only
For Point-of-care use or clinical laboratory setting.
Capillary whole blood specimens (e.g., obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre-analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration.
D Special Instrument Requirements:
i-STAT 1 Analyzer
IV Device/System Characteristics:
A Device Description:
The i-STAT G (white) cartridge with the i-STAT 1 System is a single-use and disposable unit that contains test reagents and sensors for the glucose measurement. Cartridges require two to three drops of whole blood, which are applied to the cartridge using a transfer device, by the trained user before the cartridge is placed within the analyzer. All the test steps and fluid movements occur within the i-STAT G cartridge (white). The test reagents and internal fluids do not contact the analyzer or user.
B Principle of Operation:
Glucose on the i-STAT G cartridge (white) is measured amperometrically. A voltage is applied to the cartridge electrodes with current generated by the reduction of hydrogen peroxide that was produced by catalytic oxidation of glucose present in the sample by glucose oxidase. The current is directly proportional to the concentration of the glucose in the sample.
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V Substantial Equivalence Information:
A Predicate Device Name(s):
i-STAT CHEM8+ cartridge with the i-STAT 1 System
B Predicate 510(k) Number(s):
K210958
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K223755 | K210958 |
| --- | --- | --- |
| Device Trade Name | i-STAT G cartridge with the i-STAT 1 system | i-STAT CHEM8+ cartridge with the i-STAT 1 system |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for in vitro quantification of glucose in samples. 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. | Same |
| Reportable Range | 20 – 700 mg/dL | Same |
| Traceability | NIST SRM965 | Same |
| General Device Characteristic Differences | | |
| Sample Type | Arterial and venous whole blood with and without lithium heparin or EDTA anticoagulant. Lithium Heparin capillary whole blood. | Arterial or venous whole blood with and without lithium heparin anticoagulant |
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VI Standards/Guidance Documents Referenced:
Clinical Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
CLSI EP06: Evaluation of Linearity of Quantitative Measurement Procedures; 2nd Edition.
CLSI EP07: Interference Testing in Clinical Chemistry; 3rd ed.
CLSI EP09c: Measurement Procedure Comparison and Bias Estimation using Patient Samples, 3rd ed.
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; 2nd ed.
CLSI EP35: Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures; 1st ed.
CLSI EP37: Supplement Tables for Interference Testing in Clinical Chemistry; 1st ed.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Internal Site Precision
i. 20-day Precision
A single-site precision study for the i-STAT Glucose test on the i-STAT G cartridge (white) with the i-STAT 1 System was conducted following the recommendations in the CLSI EP05-A3. Five (5) concentration levels of i-STAT Calibration Verification fluids were tested using one (1) i-STAT G cartridge lot and multiple analyzers. Each level of calibration verification fluid was measured in duplicates per run, with two runs per day for at least 20 non-consecutive days resulting in a total of 80 test results per level. The results are summarized below:
| Sample | N | Mean (mg/dL) | Repeatability | | Between-Run | | Between-Day | | Within-Laboratory | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| L1 | 80 | 25.0 | 0.43 | 1.71 | 0.06 | 0.23 | 0.34 | 1.36 | 0.55 | 2.19 |
| L2 | 80 | 38.5 | 0.38 | 0.99 | 0.22 | 0.58 | 0.21 | 0.54 | 0.49 | 1.27 |
| L3 | 80 | 119.1 | 0.69 | 0.58 | 0.21 | 0.18 | 0.31 | 0.26 | 0.78 | 0.66 |
| L4 | 80 | 272.2 | 1.42 | 0.52 | 0.40 | 0.15 | 0.76 | 0.28 | 1.66 | 0.61 |
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## ii. Between-Lot Precision
The between-lot precision study for the i-STAT Glucose test on the i-STAT G cartridge (white) with the i-STAT 1 System was conducted following the recommendations in the CLSI document EP05-A3. The study was conducted using three (3) lots of i-STAT G cartridges (white), each lot tested in five (5) replicates over five (5) non-consecutive days for each of the i-STAT Calibration Verification fluid levels using multiple analyzers. The results are summarized below:
| Sample | N* | Mean (mg/dL) | Repeatability | | Between-Lot | | Between-Day | | Within-Laboratory | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| L1 | 76 | 26.6 | 0.29 | 1.10 | 1.04 | 3.93 | 0.14 | 0.52 | 1.09 | 4.11 |
| L2 | 75 | 40.1 | 0.46 | 1.14 | 0.83 | 2.08 | 0.18 | 0.45 | 0.97 | 2.41 |
| L3 | 76 | 122.5 | 0.31 | 0.26 | 0.70 | 0.58 | 0.28 | 0.23 | 0.82 | 0.67 |
| L4 | 75 | 275.2 | 0.78 | 0.28 | 0.28 | 0.10 | 0.11 | 0.04 | 0.83 | 0.30 |
| L5 | 75 | 561.4 | 2.48 | 0.44 | 4.20 | 0.75 | 1.41 | 0.25 | 5.08 | 0.90 |
*The sample size for L1 and L3 was greater than 75 as there were additional cartridges inadvertently run.
## Point of Care (Multi-Site) Precision (aqueous control material)
Multiple-day precision testing was performed at three (3) clinical sites using a panel of aqueous material, i.e., i-STAT TriControls Calibration Verification Set, containing five (5) level of glucose concentration. At each site, testing was performed once (1) per day by two (2) operators for five (5) days and each operator performed test using one (1) lot of i-STAT G cartridges (white) on three (3) i-STAT 1 Analyzers. The combined precision study results from all sites are summarized below:
| Sample | N | Mean (mg/dL) | Repeatability | | Between-Day | | Between-Operator | | Within-Site | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| L1 | 89 | 573.1 | 2.63 | 0.46 | 1.2 | 0.21 | 0.00 | 0.00 | 2.89 | 0.5 |
| L2 | 90 | 266.3 | 0.71 | 0.27 | 0.37 | 0.14 | 0.16 | 0.06 | 0.82 | 0.31 |
| L3 | 90 | 133.7 | 0.57 | 0.43 | 0.12 | 0.09 | 0.18 | 0.13 | 0.61 | 0.46 |
| L4 | 90 | 46.1 | 0.33 | 0.72 | 0.31 | 0.67 | 0.04 | 0.09 | 0.46 | 0.99 |
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| Sample | N | Mean (mg/dL) | Repeatability | | Between-Day | | Between-Operator | | Within-Site | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| L5 | 90 | 33.7 | 0.57 | 1.68 | 0.00 | 0.00 | 0.14 | 0.40 | 0.58 | 1.73 |
| Sample | N | Mean (mg/dL) | Between-Site | | Overall | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV |
| L1 | 89 | 573.1 | 0.00 | 0.00 | 2.89 | 0.5 |
| L2 | 90 | 266.3 | 0.05 | 0.02 | 0.82 | 0.31 |
| L3 | 90 | 133.7 | 0.00 | 0.00 | 0.61 | 0.46 |
| L4 | 90 | 46.1 | 0.15 | 0.32 | 0.48 | 1.04 |
| L5 | 90 | 33.7 | 0.00 | 0.00 | 0.58 | 1.73 |
# Point of Care Precision (Whole Blood)
Whole blood precision of the i-STAT Glucose test in the i-STAT G cartridge (white) on the i-STAT 1 System was evaluated using arterial, venous, and capillary whole blood specimens collected with lithium heparin. The whole blood precision was assessed using the duplicate test results collected across multiple point of care sites. For each sample type, samples were grouped into subintervals based on their mean values. The precision results between sites were similar. The combined results from all sites are summarized below:
| Test (Unit) | Sample Type | Sample Range | N | Mean | Pooled SD | %CV |
| --- | --- | --- | --- | --- | --- | --- |
| Glucose (mg/dL) | Venous Whole Blood | 20-90 | 38 | 75.0 | 0.32 | 0.43 |
| | | >90-150 | 67 | 109.6 | 0.39 | 0.35 |
| | | >150-250 | 32 | 195.8 | 0.73 | 0.37 |
| | | >250-400 | 15 | 315.0 | 1.17 | 0.37 |
| | | >400-700 | 12 | 559.0 | 2.01 | 0.36 |
| | Arterial Whole blood | 20-90 | 9 | 82.4 | 0.33 | 0.40 |
| | | >90-150 | 94 | 125.0 | 0.57 | 0.46 |
| | | >150-250 | 64 | 182.0 | 0.54 | 0.30 |
| | | >250-700 | 6 | 357.0 | 0.91 | 0.26 |
| | Capillary Whole blood | 20-90 | 33 | 70.9 | 1.91 | 2.71 |
| | | >90-150 | 53 | 116.0 | 2.44 | 2.10 |
| | | >150-250 | 37 | 196.6 | 4.40 | 2.24 |
| | | >250-400 | 16 | 297.1 | 4.09 | 1.38 |
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2. Linearity:
The linearity study was designed based on the CLSI EP06 2nd ed guideline. The linearity of the i-STAT Glucose test in the i-STAT G cartridge (white) with the i-STAT 1 System was evaluated by preparing a total 11 samples with concentrations spanning the claimed measuring range. Each level was tested in replicates of two per cartridge lot for a total of 10 results per level. An assessment of linearity was performed using weighted least squares linear regression. At each concentration level, the deviation from linearity was within ± 3%. The regression parameters for the linearity study are summarized below:
| Total of levels | Specimen Range (mg/dL) | Claimed Measurement Range (mg/dL) | Slope | Intercept | R² |
| --- | --- | --- | --- | --- | --- |
| 11 | 15.3 – 793.3 | 20 – 700 | 1.002 | -1.258 | 0.999 |
The linearity data supported the claimed reportable range of 20 to 700 mg/dL.
3. Analytical Specificity/Interference:
The analytical specificity of the i-STAT Glucose assay on the i-STAT G cartridge (white) was established by conducting interference testing following the recommendations from CLSI EP07-3rd ed guideline. Interference from certain exogenous and endogenous substances was assessed using lithium heparin whole blood samples at two glucose concentrations: low (30 - 50 mg/dL) and high (210-230 mg/dL). The samples with high and low analyte levels were further divided into two groups: i.e., test sample (with added interferent) and control sample (without interferent). Each sample level was tested in duplicates for each of the five (5) i-STAT G cartridge lots (for a total of 10 results per level) on multiple i-STAT 1 analyzers.
The effect of each substance at each analyte level was evaluated by comparing the test results of a control sample, i.e., spiked with blank solvent solution, with the test results from a sample spiked with the potentially interfering substance at the toxic or pathological concentration based on CLSI EP37.
The sponsor defines that interference is considered non-significant if the bias between the test and control sample are within ± 10% for all test interferences. The following table lists the concentrations of each substance at which no significant interference was found.
| Substance | Highest concentration at which no interference was observed |
| --- | --- |
| Acetaldehyde | 0.2 mg/dL |
| Acetaminophen | 15.6 mg/dL |
| Acetoacetate (lithium Acetoacetate) | 20.0 mg/dL |
| Acetyl Cysteine (N-Acetyl-Cysteine) | 15.0 mg/dL |
| Ammonium (Ammonium Chloride) | 10.7 mg/dL |
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| Substance | Highest concentration at which no interference was observed |
| --- | --- |
| Ascorbic Acid (L-Ascorbic Acid) | 5.25 mg/dL |
| β – Hydroxybutyric Acid | 62.46 mg/dL |
| Bilirubin | 40 mg/dL |
| Bromide | 21.7 mg/dL (2.5mmol/L) |
| Cholesterol | 400 mg/dL |
| Creatinine | 15 mg/dL |
| Dopamine (Dopamine Hydrochloride) | 0.0621mg/dL |
| Ethanol | 600 mg/dL |
| Fluoride (Lithium Fluoride) | 0.12 mg/dL |
| Formaldehyde | 0.399 mg/dL |
| Fructose | 18 mg/dL |
| Galactose | 60 mg/dL |
| Gentisic Acid | 1.5 mg/dL |
| Gentamicin | 3 mg/dL |
| Glucosamine (Glucosamine Hydrochloride) | 0.647 mg/dL |
| Glutathione, reduced | 3 mEq/L |
| Glycolic Acid | 76.05 mg/dL |
| Guaifenesin | 0.45 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Heparin (sodium heparin) | 330 U/dL |
| Ibuprofen | 21.9 mg/dL |
| Intralipid 20% | 3151 mg/dL |
| Lactate (lithium lactate) | 90 mg/dL |
| Maltose | 360 mg/dL |
| Mannose | 18.02 mg/dL |
| Nithiodote (sodium thiosulfate) | 264.04 mg/dL |
| pH | 8.0 pH units |
| Pyruvate (lithium pyruvate) | 5 mg/dL |
| Salicylate (lithium salicylate) | 2.86 mg/dL |
| Thiocyanate (lithium thiocyanate) | 5.22 mg/dL |
| Triglyceride | 1500 mg/dL |
| Uric Acid | 23.5 mg/dL |
| Xylose | 45.04 mg/dL |
For those substances that on initial screening were found to interfere with the glucose results, dose response testing was conducted to establish the concentration limit below which no significant interference is expected. The results are given in the table below:
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| Substance | Interference Concentration Resulting in the Shift in the Glucose Test Concentration | Glucose Results Shift Direction |
| --- | --- | --- |
| Lithium bromide | ≥ 15.88 mmol/L | Decreased glucose results |
| Hydroxyurea | ≥ 0.08 mmol/L | Increased glucose results |
| Isoniazid* | ≥ 0.29 mmol/L | Increased glucose results |
*Isoniazid interferes at low glucose concentration.
The sponsor included the following statements in the labeling:
- Bromide at 2.5 mmol/L is the peak plasma concentration associated with halothane anesthesia, in which bromide is released.
- Hydroxyurea is a DNA synthesis inhibitor used in the treatment of sickle cell anemia, HIV infection, and various types of cancer. The malignancies that it is used to treat include melanoma, metastatic ovarian cancer, and chronic myelogenous leukemia. It is also used in the treatment of polycythemia vera, thrombocythemia, and psoriasis. At typical doses ranging from 500 mg to 2 g/day, concentrations of hydroxyurea in a patient’s blood may be sustained at approximately 0.1 to 0.5 mmol/L (100 to 500 μmol/L). Higher concentrations may be observed soon after dosing or at higher therapeutic doses.
The sponsor conducted studies to assess the effect of oxygen on the i-STAT G cartridge (white) on the i-STAT 1 System. Protocols and results were reviewed and found acceptable to support that the test is insensitive to oxygen levels between 21 and 515 mmHg.
The sponsor conducted studies to assess the effect of hematocrit on the i-STAT G cartridge (white) on the i-STAT 1 System. Protocols and results were reviewed and found acceptable to support that the test is insensitive to hematocrit levels between 15% to 75%.
The sponsor conducted studies to assess the effect of altitude on the i-STAT G cartridge (white) on the i-STAT 1 System. Protocols and results were reviewed and found acceptable to support that the test yields accurate results up to approximately 10,000 feet above sea level.
4. Assay Reportable Range:
See section A.2 Linearity.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Traceability
The glucose assay on the i-STAT G cartridge is traceable to the U.S. National Institute of Standards and Technology (NIST) standard reference material SRM965.
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## Sample Stability
A study was conducted to verify the whole blood sample stability after sample collection with and without anticoagulants for the i-STAT G cartridge (white) on the i-STAT 1 Analyzer. The results support the sponsor’s sample stability claims.
## 6. Detection Limit:
Detection capability studies of limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ) for i-STAT G Glucose test on the i-STAT G cartridge (white) with the i-STAT 1 analyzer were conducted following the recommendations in CLSI EP17-A2.
The LoB was evaluated for the i-STAT G cartridge (white) using lithium heparin whole blood samples altered to create blank samples. The samples were tested across three days using two lots of the i-STAT G cartridge (white). The LoB for each lot was calculated following the EP17-A2 guideline. The higher of the two LoB values from each lot is reported as the LoB.
The LoD was evaluated using lithium heparin venous whole blood samples that were altered to create four (4) samples with low concentrations of glucose. Each of the low samples was measured using 20 i-STAT G cartridges (white) from each of two (2) cartridge lots. The LoD was calculated for each lot following the EP17-A2 guideline. The higher of the two LoD values from each lot is reported as the LoD.
The LoQ was evaluated using lithium heparin venous whole blood samples that were altered to create four (4) samples with low concentrations of glucose. Each sample was measured in twelve (12) replicates per lot across two i-STAT G cartridge lots. The LoQ was calculated for each of the two lots. The LoQ was defined as the greater of the two lots at which the lowest concentration met the pre-defined total error goal, i.e., $\leq 6\mathrm{mg / dL}$.
The results from all studies are summarized in the table below:
| Analyte | Measuring Range | LoB | LoD | LoQ |
| --- | --- | --- | --- | --- |
| Glucose | 20 -700 mg/dL | 0 mg/dL | 0.7 mg/dL | 14 mg/dL |
## 7. Assay Cut-Off:
Not Applicable.
## B Comparison Studies:
### 1. Method Comparison with Predicate Device:
A method comparison study was conducted following the recommendations in CLSI EP09c-3rd ed guideline.
Lithium heparin arterial (n=173) (6.1% contrived samples) and venous whole blood (n=164) specimens collected across three (3) point of care sites were evaluated for glucose using the i-STAT G cartridge (white) on the i-STAT 1 analyzer and the i-STAT CHEM8+ cartridge on
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the i-STAT 1 analyzer (comparative method). A Passing-Bablok linear regression analysis was performed using the first replicate result from the i-STAT G cartridge (white) on the i-STAT 1 analyzer versus the mean result of the comparative method. Accuracy results for arterial and venous whole blood specimens are shown in the table below.
| | N | i-STAT G Range (mg/dL) | Comparative Devices Range (mg/dL) | Slope | Intercept | r | Claimed Measuring range (mg/dL) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Venous | 164 | 23-680 | 22-682 | 1.00 | 1.50 | 1.00 | 20-700 |
| Arterial | 173 | 69-518 | 66-511 | 1.00 | 1.00 | 1.00 | 20-700 |
Capillary whole blood specimens (n=234) (4.7% contrived samples and samples from neonates) collected from skin punctures with balanced heparin capillary tubes from each study subject across multiple point of care sites were tested for glucose using the i-STAT G cartridge (white) on the i-STAT 1 analyzer and the epoc Blood Analysis System (comparator method, k200107). A Passing-Bablok linear regression analysis was performed using the singlicate result from the i-STAT G cartridge (white) versus the singlicate result of the comparative method. Accuracy results for capillary whole blood specimens are shown in the table below.
| | N | i-STAT G Range (mg/dL) | Comparative Device Range (mg/dL) | Slope | Intercept | r | Claimed Measuring range (mg/dL) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Capillary blood (all samples) | 234 | 27-678 | 21-676 | 1.00 | 2.00 | 1.00 | 20-700 |
| Capillary blood (native samples only) | 223 | 47-483 | 49-459 | 1.00 | 2.00 | 0.99 | |
2. Matrix Comparison:
The sponsor has provided the information to support that the glucose in the i-STAT G cartridge (white) on the i-STAT 1 System can be performed using lithium heparin, K₂ EDTA, K₃EDTA and non-anticoagulant venous and arterial whole blood. The assay can also be used for testing heparinized capillary whole blood.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
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2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Expected values for the glucose assay on the i-STAT G cartridge (white) are cited from literature*:
| Age | Reference Range ** (mg/dL) |
| --- | --- |
| Premature | 20 – 60 |
| Neonate | 30 – 60 |
| Newborn 1 day | 40 – 60 |
| Newborn > 1 day | 50 – 80 |
| Child | 60 – 100 |
| Adult | 70 – 105 |
**for serum specimens
*P. C. Painter, J. Y. Cope, J. L. Smith, “Reference Ranges, Table 41-20” in Tietz Textbook of Clinical Chemistry – Second Edition, C.A. Burtis and E.R. Ashwood, eds.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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