Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic device that measures glucose using electrochemical sensors. There is no mention of AI, ML, or any computational methods that would suggest their use in data analysis or interpretation beyond basic signal processing.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) medical device used for the quantification of glucose, which assists in diagnosis and monitoring, not direct treatment or therapy.

Diagnostic

Yes

The text explicitly states: "The i-STAT 1 System is an in vitro diagnostic (IVD) medical device" and "Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders".

SaMD (Software as a Medical Device)

No

The device description clearly outlines a system that includes hardware components: the i-STAT 1 analyzer (a handheld device) and the i-STAT G cartridge (a disposable test cartridge with sensors, fluid pack, etc.). While software is undoubtedly part of the system (likely within the analyzer), the device as a whole is not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is for "in vitro quantification of glucose in arterial. venous or capillary whole blood". "In vitro" means outside of the living body, which is a key characteristic of IVDs.
Device Description: The "Device Description" section clearly states, "The i-STAT 1 System is an in vitro diagnostic (IVD) medical device". It also describes the components (analyzer, cartridges, controls) which are typical of an IVD system.
Function: The device measures a substance (glucose) in a biological sample (whole blood) to provide information for the diagnosis, monitoring, and treatment of medical conditions (carbohydrate metabolism disorders). This is the core function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, and pancreatic islet cell carcinoma.

Product codes (comma separated list FDA assigned to the subject device)

CGA

Device Description

The i-STAT G cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure glucose in arterial, venous, or capillary whole blood for the diagnosis, monitoring, and treatment of metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 Sustem, including the i-STAT G cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.

The i-STAT G cartridge contains the required sensors and a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within the cartridge. The test is contained in a single-use, disposable cartridge. All the test steps and fluid movements occur within the i-STAT G cartridge. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device, by the trained user before the cartridge is placed within the analyzer.

The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The analyzer interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical professionals in point of care or clinical laboratory settings

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance

Precision/Reproducibility:
- 20 days (aqueous materials): Evaluated using five levels of aqueous material. Study based on CLSI document EP05-A3. Conducted at one site over at least 20 days using multiple analyzers and one test cartridge lot.
  - Results (Table 1):
    - CV L1 (25.0 mg/dL): SD 0.55, %CV 2.19
    - CV L2 (38.5 mg/dL): SD 0.49, %CV 1.27
    - CV L3 (119.1 mg/dL): SD 0.78, %CV 0.66
    - CV L4 (272.2 mg/dL): SD 1.66, %CV 0.61
    - CV L5 (565.5 mg/dL): SD 5.41, %CV 0.96
- Multi-site and operator-to-operator precision (aqueous materials): Performed at three sites using a panel of aqueous material with five glucose levels. At each site, testing was done once per day by two operators for five days on six i-STAT 1 analyzers using one lot of i-STAT G cartridges.
  - Results (Table 2, Overall):
    - CV L1 (573.1 mg/dL): SD 2.89, %CV 0.50
    - CV L2 (266.3 mg/dL): SD 0.82, %CV 0.31
    - CV L3 (133.7 mg/dL): SD 0.61, %CV 0.46
    - CV L4 (46.1 mg/dL): SD 0.48, %CV 1.04
    - CV L5 (33.7 mg/dL): SD 0.58, %CV 1.73
- Precision (whole blood): Evaluated using arterial, venous, and capillary whole blood specimens collected with lithium heparin. Assessed using duplicate test results from multiple point of care sites.
  - Results (Table 3, Glucose mg/dL):
    - Venous whole blood (20-700 mg/dL range): SD 0.32-2.01, %CV 0.36-0.43
    - Arterial whole blood (20-700 mg/dL range): SD 0.33-0.91, %CV 0.26-0.46
    - Capillary whole blood (20-700 mg/dL range): SD 1.92-4.40, %CV 1.38-2.71
Linearity/assay reportable range:
- Linearity: Study based on CLSI EP06-Ed2. Evaluated by preparing whole blood samples of varying glucose levels across the reportable range.
  - Results (Table 4): Showed linearity over the reportable range of 20 - 700 mg/dL. Slope 1.002, Intercept -1.258, R2 0.999.
Detection Limit
- Limit of Quantitation (LoQ): Study based on CLSI EP17-A2. Evaluated using two cartridge lots and whole blood altered to a low glucose level.
  - Results (Table 5): LoQ determined to be 14 mg/dL.
- Limit of Blank and Detection (LoB/LoD): Study based on CLSI EP17-A2. Evaluated using two cartridge lots, with whole blood altered to blank or low glucose levels.
  - Results (Table 6): LoB 0 mg/dL, LoD 0.7 mg/dL for glucose.
Analytical Specificity
- Interference: Study based on CLSI EP07-ED3. Evaluated using whole blood samples at low and high glucose levels for various substances. A substance was identified as an interferent if the difference in means (or medians) was outside of the glucose allowable error (±Ea).
  - Results (Table 7): Most substances showed no interference (e.g., Acetaminophen, Ascorbic Acid, Bilirubin). Identified interferents: Bromide (at 37.5 mmol/L), Hydroxyurea (increased results ≥ 0.08 mmol/L), Isoniazid (increased results ≥ 0.29 mmol/L).
- Other sensitivity studies:
  - Oxygen Sensitivity: Evaluated with low and high oxygen levels using whole blood samples at four glucose levels. The 95% confidence interval of the difference in means was within the allowable error (±Ea).
    - Key results: Insensitive to oxygen levels between 21 and 515 mmHg.
  - Hematocrit Sensitivity: Assessed at three hematocrit levels (low, mid, high) and four glucose levels. The difference between low/high and mid hematocrit levels was within the allowable error (±Ea).
    - Key results: Insensitive to hematocrit levels between 15% to 75% packed cell volume (PCV).
  - Altitude: Performed at approximately 10,000 feet above sea level. Glucose test results compared to predicate device. Passing-Bablok regression analyses performed.
    - Key results (Table 8): Correlation Coefficient (r) was 0.97 (95% Cl 0.964 to 0.972), Slope was 1.00 (95% Cl 1.000 to 1.000). Demonstrated equivalent performance.

Comparison Studies

Method Comparison with Comparator Device: Study based on CLSI EP09c-ED3.
- Samples: Lithium heparin arterial and venous whole blood specimens collected across multiple point of care sites were compared against the i-STAT CHEM8+ cartridge on the i-STAT 1 analyzer. Capillary whole blood specimens from skin punctures were compared against the epoc Blood Analysis System.
- Analysis: Pooled arterial, venous, and capillary whole blood data, performed Passing-Bablok linear regression.
- Results (Table 9):
  - Overall Glucose (Arterial/Venous vs. i-STAT CHEM8+, Capillary vs. epoc Blood Analysis System): N 571, Slope 1.00, Intercept 1.85, r 1.00.
- Results by sample type (Table 10):
  - Arterial: N 173, Slope 1.00, Intercept 1.00, r 1.00.
  - Venous: N 164, Slope 1.00, Intercept 1.50, r 1.00.
  - Capillary: N 234, Slope 1.00, Intercept 2.00, r 1.00.
Matrix Equivalence: Study based on CLSI EP35. Evaluated performance using non-anticoagulated arterial or venous whole blood specimens compared to heparinized whole blood. Each specimen tested in duplicate using two i-STAT G cartridges with two i-STAT 1 analyzers. Passing-Bablok linear regression performed.
- Results (Table 11): N 158, Candidate Specimen Range 42-679 mg/dL, Primary Specimen Range 42-681 mg/dL, r 1.00, Slope 1.00, Intercept 0.00.
EDTA Matrix Equivalence: Study based on CLSI EP35. Evaluated matrix equivalency between lithium heparin (primary) and K2EDTA and K3EDTA (candidate) anticoagulants. Each specimen tested in duplicate. Passing-Bablok regression analysis performed.
- K2EDTA vs lithium heparin (Table 12): N 43, K2EDTA Candidate Specimen Range 30.3 – 522.9 mg/dL, LiHep Primary Specimen Range 29.5 – 510.9 mg/dL, r 1.00, Slope 1.03, Intercept -1.037.
- K3EDTA vs lithium heparin (Table 13): N 43, K3EDTA Candidate Specimen Range 30.4 – 520.6 mg/dL, LiHep Primary Specimen Range 29.5 – 510.9 mg/dL, r 1.00, Slope 1.03, Intercept 0.015.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K210958 (K183678)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 11, 2023

Mojgan Soleimani Associate Director Regulatory Affairs Abbott Point of Care Inc. 400 College Road East Princeton, New Jersey 08540

Re: K223755

Trade/Device Name: i-STAT G cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA Dated: August 8, 2023 Received: August 9, 2023

Dear Mojgan Soleimani:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

1

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223755

Device Name i-STAT G cartridge on the i-STAT 1 System

Indications for Use (Describe)

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, and pancreatic islet cell carcinoma.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Abbott logo. The logo consists of a blue abstract shape on the left and the word "Abbott" in black on the right. The abstract shape is a stylized letter "A" with rounded corners. The word "Abbott" is in a bold, sans-serif font.

510(k) SUMMARY

The information in this 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER INFORMATION

| Owner | Abbott Point of Care Inc.
400 College Road East
Princeton, NJ 08540 |
|---------------|----------------------------------------------------------------------------------------------|
| Contact | Primary: Mojgan Soleimani
Associate Director Regulatory Affairs
Phone: +1 613-295-0932 |
| | Secondary: Robert Gregg
Director Regulatory Affairs
Phone: +1 609-454-9360 |
| Date Prepared | September 11, 2023 |

II. DEVICE INFORMATION

Proprietary Name	i-STAT G cartridge with the i-STAT 1 System
Common Name	Glucose test, analyzer, handheld
510(k) Number:	K223755

| Product
Code | Device Classification Name | Regulation
Number | Class | Panel |
|-----------------|----------------------------|----------------------|-------|--------------------|
| CGA | Glucose oxidase, Glucose | 862.1345 | II | Clinical Chemistry |

III. PREDICATE DEVICE

Proprietary Name

i-STAT CHEM8+ cartridge with the i-STAT 1 System

510(k) Number

K210958 (K183678)

| Product
Code | Device Classification
Name | Regulation
Number | Class | Panel |
|-----------------|-------------------------------|----------------------|-------|--------------------|
| CGA | Glucose oxidase, Glucose | 862.1345 | II | Clinical Chemistry |

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IV. DEVICE DESCRIPTION

The i-STAT G cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure glucose in arterial, venous, or capillary whole blood for the diagnosis, monitoring, and treatment of metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 Sustem, including the i-STAT G cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.

The i-STAT G cartridge contains the required sensors and a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within the cartridge. The test is contained in a single-use, disposable cartridge. All the test steps and fluid movements occur within the i-STAT G cartridge. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device, by the trained user before the cartridge is placed within the analyzer.

The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The analyzer interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

V. INTENDED USE STATEMENT

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.

Similarities and Differences (Test and Instrument)
	Candidate Devices	Predicate Devices

VI. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Similarities and Differences (Test and Instrument)
Feature or
Characteristic	Candidate Device:
Glucose test in the i-STAT G cartridge
with the i-STAT 1 System	Predicate Device:
Glucose test in the i-STAT CHEM8+
cartridge with the i-STAT 1 System
K210958 (K183678)
Intended 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.	The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in
Similarities and Differences (Test and Instrument)
Feature or
Characteristic	Candidate Device:
Glucose test in the i-STAT G cartridge
with the i-STAT 1 System	Predicate Device:
Glucose test in the i-STAT CHEM8+
cartridge with the i-STAT 1 System
K210958 (K183678)
	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.	arterial or venous whole blood in point of
care or clinical laboratory settings.

The glucose test in the i-STAT CHEM8+
cartridge with the i-STAT 1 System is
intended for use in the in vitro
quantification of glucose in arterial or
venous whole blood in point of care or
clinical laboratory settings.

With anticoagulant:
Capillary within 3 minutes
Arterial and venous within 30 minutes | Without anticoagulant:
Arterial and venous within 3 minutes

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VII. PERFORMANCE CHARACTERISTICS

A. Analytical Performance

a. Precision/Reproducibility:

i. Precision 20 days (aqueous materials)

The precision of the i-STAT Glucose test in the i-STAT G cartridge with the i-STAT 1 System was evaluated using five (5) levels of aqueous material. This single-site 20-day multi-day precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition. The study was conducted using multiple analyzers and one (1) test cartridge lot over at least 20 days at one (1) site. Repeatability, between-run, between-day, and within-laboratory precision were estimated for each level. The results of the 20-day precision study are shown in Table 1.

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Table 1: Results of 20-Day precision of the i-STAT Glucose test on the i-STAT 1 analyzer using i-STAT Calibration Verification set (mg/dL)

| Fluid Level | N | Mean
(mg/dL) | Repeatability | | Between-run | | Between-day | | Within-Laboratory | |
|-------------|----|-----------------|---------------|------|-------------|------|-------------|------|-------------------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| CV L1 | 80 | 25.0 | 0.43 | 1.71 | 0.06 | 0.23 | 0.34 | 1.36 | 0.55 | 2.19 |
| CV L2 | 80 | 38.5 | 0.38 | 0.99 | 0.22 | 0.58 | 0.21 | 0.54 | 0.49 | 1.27 |
| CV L3 | 80 | 119.1 | 0.69 | 0.58 | 0.21 | 0.18 | 0.31 | 0.26 | 0.78 | 0.66 |
| CV L4 | 80 | 272.2 | 1.42 | 0.52 | 0.40 | 0.15 | 0.76 | 0.28 | 1.66 | 0.61 |
| CV L5 | 80 | 565.5 | 4.33 | 0.77 | 2.71 | 0.48 | 1.78 | 0.32 | 5.41 | 0.96 |

ii. Multi-site and operator-to-operator precision (aqueous materials)

Multi-day precision testing was performed at three (3) sites using a panel of aqueous material containing five (5) levels of glucose. At each site, testing was performed once per day by two (2) operators for five (5) days on six (6) i-STAT 1 analyzers using one (1) lot of i-STAT G cartridges. Within-run, between-day, between-operator and within-site (total) variance components were calculated by site. These components were also calculated for all sites combined and provided in the Table 2 below.

Table 2: Results of point of care multi-day precision of i-STAT Glucose test on the i-STAT 1 analyzer using i-STAT TriControls Calibration Verification set (mg/dL)

Fluid Level	N	Mean	Within-Run		Between-Day		Between-Operator		Within-Site (Total)		Between-Site		Overall
			SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
CV L1	89	573.1	2.63	0.46	1.20	0.21	0.00	0.00	2.89	0.50	0.00	0.00	2.89	0.50
CV L2	90	266.3	0.71	0.27	0.37	0.14	0.16	0.06	0.82	0.31	0.05	0.02	0.82	0.31
CV L3	90	133.7	0.57	0.43	0.12	0.09	0.18	0.13	0.61	0.46	0.00	0.00	0.61	0.46
CV L4	90	46.1	0.33	0.72	0.31	0.67	0.04	0.09	0.46	0.99	0.15	0.32	0.48	1.04
CV L5	90	33.7	0.57	1.68	0.00	0.00	0.14	0.40	0.58	1.73	0.00	0.00	0.58	1.73

iii. Precision (whole blood)

Whole blood precision of the i-STAT Glucose test in the i-STAT G cartridge 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 results are summarized in Table 3.

| Test

(units)	Sample Type	Sample Range	N	Mean	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

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	>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	1.92	2.71
	>90-150	53	116.0	2.44	2.10
	>150-250	37	196.6	4.40	2.24
	>250-700	16	297.1	4.09	1.38

b. Linearity/assay reportable range:

i. Linearity

The study was designed based on CLSI EP06-Ed2: Evaluation of Linearity of Quantitative Measurement Procedures - Second Edition.

The linearity of the i-STAT Glucose test in the i-STAT G cartridge with the i-STAT 1 System was evaluated by preparing whole blood samples of varying glucose levels across the reportable range for the test. The i-STAT Glucose test in the i-STAT G cartridge on the i-STAT 1 System demonstrated linearity over the reportable range of 20 - 700 mg/dL. Regression summary of the response for the i-STAT Glucose test versus the concentration of the whole blood samples of varying glucose levels is provided in Table 4.

Test	Units	Reportable Range	Range Tested	Slope	Intercept	R2
Glucose	mg/dL	20-700	15.3 – 793.3	1.002	-1.258	0.999

c. Detection Limit

Limit of Quantitation (LoQ) i.

The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.

The LoQ of the i-STAT Glucose test in the i-STAT G cartridge was evaluated on the i-STAT 1 analyzer using two (2) cartridge lots and whole blood that was altered to a low glucose level. The LoQ for the i-STAT Glucose test was determined to be 14 mg/dL, which is below the lower limit of the reportable range for the i-STAT Glucose test as shown in Table 5.

Table 5: LoQ result for the i-STAT Glu test in the i-STAT G cartridge
Test	Lower limit of the reportable range	LoQ
Glucose	20 mg/dL	14 mg/dL

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ii. Limit of Blank and Detection (LoB/LoD)

The study was based on CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.

The LoB and LoD of the i-STAT Glucose test in the i-STAT G cartridge were evaluated on the i-STAT 1 analyzer using two (2) cartridge lots. Whole blood was altered to a blank glucose level for LoB testing and two (2) low glucose levels for LoD testing. The LoB and LoD were determined based on the maximal LoB or LoD value obtained for each lot tested. The LoB and LoD for the i-STAT Glucose test on the i-STAT 1 analyzer was determined as shown in the Table 6 below.

Table 6: Summary of LoB and LoD results for the i-STAT G cartridge
Test	LoB	LoD
Glucose	0 mg/dL	0.7 mg/dL

d. Analytical Specificity

i. Interference

The study was based on CLSI EP07-ED3: Interference Testing in Clinical Chemistry - Third Edition.

The interference performance of the i-STAT Glucose test in the i-STAT G cartridge on the i STAT 1 analyzer with the i-STAT 1 System was evaluated using whole blood samples at low and high glucose levels for all substances. The effect of each substance was evaluated by comparing the test results of a control sample, spiked with blank solvent solution, with the test results from a test sample spiked with the potentially interfering substance at the toxic or pathological concentration based on CLSI EP37-ED1: Supplemental Tables for Interference Testing in Clinical Chemistry, First Edition, as applicable. A substance was identified as an interferent if the difference in means (or medians) between the control and test samples was outside of the glucose allowable error (±Ea). For an identified interferent, a dose-response analysis was performed to determine the degree of interference as a function of the substance concentration.

Table 7 contain the lists of potentially interfering substances tested for the i-STAT Glucose test and the interference results.

Table 7: Potentially interfering substances and test concentrations for the i-STAT Glucose
test in the i-STAT G cartridge
Substance	Substance
Concentration
(mmol/L)	Substance
Concentration
(mg/dL)	Test	Interference
(Yes/No)	Comment
Acetaldehyde	0.045	0.2	Glu	No
Acetaminophen	1.03	15.6	Glu	No
Acetoacetate
(Lithium Acetoacetate)	2.0	20	Glu	No
Table 7: Potentially interfering substances and test concentrations for the i-STAT Glucose
test in the i-STAT G cartridge
Substance	Substance
Concentration
(mmol/L)	Substance
Concentration
(mg/dL)	Test	Interference
(Yes/No)	Comment
Acetyl Cysteine
(N-Acetyl-L-
Cysteine)	0.92	15.0	Glu	No
Ammonium
(Ammonium
Chloride)	2.0	10.7	Glu	No
Ascorbic Acid
(L-Ascorbic
Acid)	0.298	5.25	Glu	No
β-
Hydroxybutyric
Acid	6.0	62.46	Glu	No
Bilirubin	0.684	40	Glu	No
Bromide	2.5	21.7	Glu	No
(Lithium
Bromide)	37.5	325.7	Glu	Yes	Use another method.
Cholesterol	10.3	400	Glu	No
Creatinine	1.326	15	Glu	No
Dopamine
(Dopamine
Hydrochloride)	4.06 µmol/L	0.0621	Glu	No
Ethanol	130	600	Glu	No
Fluoride
(Lithium
Fluoride)	0.0632	0.12	Glu	No
Formaldehyde	0.133	0.399	Glu	No
Fructose	1	18	Glu	No
Galactose	3.33	60	Glu	No
Gentamicin
(Gentamicin
Sulfate)	0.0628	3	Glu	No
Gentisic Acid	0.0973	1.5	Glu	No
Glucosamine
(Glucosamine
Hydrochloride)	0.030	0.647	Glu	No
Glutathione,
reduced	3	3 mEq/L	Glu	No
Glycolic Acid	10.0	76.05	Glu	No
Guaifenesin	0.0227	0.45	Glu	No
Hemoglobin	10 g/L	1000	Glu	No
Heparin
(Sodium
Heparin)	3.30 U/mL	330 U/dL	Glu	No
Hydroxyurea	0.405	3.08	Glu	Yes	Increased results ≥ 0.08
mmol/L.
Ibuprofen	1.06	21.9	Glu	No
Intralipid 20%	N/A	3151	Glu	No

10

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Table 7: Potentially interfering substances and test concentrations for the i-STAT Glucose
test in the i-STAT G cartridge
Substance	Substance
Concentration
(mmol/L)	Substance
Concentration
(mg/dL)	Test	Interference
(Yes/No)	Comment
Isoniazid	0.438	6	Glu	Yes	Increased results ≥ 0.29
mmol/L.
Lactate
(Lithium
Lactate)	10	90	Glu	No
Maltose	10.5	360	Glu	No
Mannose	1	18.02	Glu	No
Nithiodote
(Sodium
Thiosulfate)	16.7	264.04	Glu	No
pH	8.0 pH units	N/A	Glu	No
Pyruvate
(Lithium
Pyruvate)	0.570	5	Glu	No
Salicylate
(Lithium
Salicylate)	0.207	2.86	Glu	No
Thiocyanate
(Lithium
Thiocyanate)	0.898	5.22	Glu	No
Triglyceride	16.94	1500	Glu	No
Uric Acid	1.4	23.5	Glu	No
Xylose	3	45.04	Glu	No

ii. Other sensitivity studies

1) Oxygen Sensitivity

The effect of oxygen on the i-STAT Glucose test in the i-STAT G cartridge on the i-STAT 1 System was evaluated with low and high oxygen levels using whole blood samples altered to four (4) glucose levels across the reportable range of the i-STAT Glucose test. The equivalency between the high and low oxygen conditions was determined if the 95% confidence interval (CI) of the difference in means (or medians) was within the allowable error (+ Ea).

The study demonstrated that i-STAT Glucose test in the i-STAT G cartridge with the i-STAT 1 System is insensitive to oxygen levels between 21 and 515 mmHg.

2) Hematocrit Sensitivity

The effect of hematocrit on the i-STAT Glucose test in the i-STAT G cartridge with the i-STAT 1 System was assessed. Three (3) hematocrit levels (low, mid and high) were evaluated at four (4) glucose levels across the reportable range of the i-STAT Glucose test in the i-STAT G cartridge. The hematocrit sensitivity at each glucose level was assessed by comparing the results at the low and high hematocrit level to the mid hematocrit level. Equivalency was assessed by determining whether the difference between the low and high hematocrit level

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and the mid hematocrit level was within the allowable error (±Ea). The study demonstrated that i-STAT Glucose test in the i-STAT G cartridge with the i-STAT 1 System is insensitive to hematocrit levels between 15% to 75% packed cell volume (PCV).

3) Altitude

The performance of the i-STAT Glucose test in the i-STAT G cartridge on the i-STAT 1 analyzer was evaluated at an altitude of approximately 10,000 feet above sea level using whole blood samples across the reportable range. The glucose test results obtained from the i-STAT G cartridges (candidate device) were compared to the glucose test results obtained from the i-STAT CHEM8+ cartridges on the i-STAT 1 analyzer (comparator device). Passing-Bablok regression analyses between the 1st replicate of the candidate device (v-axis) and mean of the comparator device (x-axis) were performed based on the CLSI cc: Measurement Procedure Comparison and Bias Estimation using Patient Samples, Third Edition. The results of the correlation coefficient and slope met acceptance criteria and demonstrate equivalent performance between the candidate and comparator condition at approximately 10,000 feet above sea level. The results are summarized in Table 8 below.

Table 8: Summary of altitude study results for the i-STAT G cartridge Correlation Coefficient (r) Slope Test 95% Cl 95% Cl r Slope

0.97

0.964 to 0.972

B. Comparison Studies

Glucose

a. Method Comparison with Comparator Device

1.00

Method comparison was demonstrated in studies based on CLSI EP09c-ED3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples -Third Edition. Lithium heparin arterial and venous whole blood specimens collected across multiple point of care sites were evaluated using the first replicate result from the i-STAT G cartridge on the i-STAT 1 analyzer versus the mean result from the i-STAT CHEM8+ cartridge on the i-STAT 1 analyzer.

1.000 to 1.000

In addition, two (2) capillary whole blood specimens collected from skin punctures with balanced heparin capillary tubes from each study subject across multiple point of care sites were evaluated using the singlicate result from the i-STAT G cartridge on the i-STAT 1 analyzer versus the singlicate result from the epoc Blood Analysis System.

The arterial, venous, and capillary whole blood data were pooled, and a Passing-Bablok linear regression analysis was performed using the results from the i-STAT G cartridges on the i-STAT 1 analyzer versus the comparative method results. Method comparison results for arterial, venous, and capillary whole blood specimens are shown in Table 9. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.

Table 9: Method comparison results for i-STAT G cartridge with i-STAT 1 System

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Test	Comparative Method		N	Slope
	Arterial/Venous	Capillary
Glu	i-STAT CHEM8+	epoc Blood Analysis
System	571	1.00	1.85	1.00

A Passing-Bablok linear regression analysis was performed using the results of each sample from the i-STAT G cartridges on the i-STAT 1 analyzer versus the comparative method results. Method comparison results for arterial, venous and capillary whole blood specimens are shown in Table 10. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.

| Table 10: Method comparison results for i-STAT G cartridge with i-STAT 1 System by

sample type
Test	Sample Type	Comparative Method	N	Slope	Intercept
	Sample Type	Comparative Method	N	Slope	Intercept	r
Glu	Arterial	i-STAT CHEM8+	173	1.00	1.00	1.00
	Venous	i-STAT CHEM8+	164	1.00	1.50	1.00
	Capillary	epoc Blood Analysis System	234	1.00	2.00	1.00

b. Matrix Equivalence

A matrix equivalence study was conducted to evaluate the performance of the i-STAT Glucose test in the i-STAT G cartridge on the i-STAT 1 analyzer using nonanticoagulated arterial or venous whole blood specimens compared to heparinized whole blood specimens. The study design and analysis method were based on CLSI EP35: Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures – First Edition. The matrix equivalence was assessed by comparing arterial or venous specimens collected without anticoagulant (candidate specimen type) to samples collected with balanced heparin or lithium heparin anticoagulant (primary specimen type). Each specimen was tested in duplicate using two (2) i-STAT G cartridges with two (2) i-STAT 1 analyzers. A Passing-Bablok linear regression analysis was performed using the first replicate result from the candidate (y-axis) versus the mean result from the primary specimen (x-axis). The regression analysis results are summarized in Table 11. In the table. N is the number of specimens in the data set, and r is the correlation coefficient.

Table 11: Matrix equivalence results
N	Candidate Specimen Range
(mg/dL)	Primary Specimen Range
(mg/dL)	r	Slope	Intercept
158	42-679	42-681	1.00	1.00	0.00

c. EDTA Matrix Equivalence

A study was conducted to evaluate matrix equivalency between whole blood sample collected in lithium heparin (primary specimen type) and ethylenediaminetetraacetic acid (K2EDTA and K3EDTA) anticoagulants (candidate specimen types) and tested with the i-STAT Glucose test in the i-STAT G cartridge on the i-STAT 1 analyzer. The

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study design was based on CLSI EP35: Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures – First Edition. Each specimen was tested in duplicate using two (2) i-STAT G cartridges with i-STAT 1 analyzers. A Passing-Bablok regression analysis was performed using the first valid result of the K2EDTA and K3EDTA anticoagulated specimen types versus the first valid result of the specimens with lithium heparin. The regression analysis results are summarized in Table 12 and Table 13.

Table 12: Passing-Bablok regression summary for K₂EDTA vs lithium heparin
N	K₂EDTA
Candidate Specimen Range
(mg/dL)	LiHep
Primary Specimen Range
(mg/dL)	r	Slope	Intercept
43	30.3 – 522.9	29.5 – 510.9	1.00	1.03	-1.037

Table 13: Passing-Bablok regression summary for K3EDTA vs lithium heparin
N	K3EDTA
Candidate Specimen Range
(mg/dL)	LiHep
Primary Specimen Range
(mg/dL)	r	Slope	Intercept
43	30.4 – 520.6	29.5 – 510.9	1.00	1.03	0.015

CONCLUSION VIII.

The results of these studies demonstrate that performance of the i-STAT Glucose test in the i-STAT G cartridge with the i-STAT 1 System is substantially equivalent to the predicate device.