GEM Premier ChemSTAT

K223090 · Instrumentation Laboratory CO · CGA · Jan 27, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223090
• Device Name: GEM Premier ChemSTAT
• Applicant: Instrumentation Laboratory CO
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 27, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The GEM Premier ChemSTAT is a portable, automated blood gas/electrolyte/metabolite/hematocrit analyzer intended for use by healthcare professionals in a clinical setting. It is designed for the in vitro measurement of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, creatinine, urea nitrogen, bicarbonate, and hematocrit in whole blood samples.

Device Story

Portable critical care system; analyzes lithium heparinized whole blood samples via aspiration. Uses potentiometry (pH, pCO2, tCO2, Na+, K+, Cl-, Ca++, BUN), amperometry (glucose, lactate, creatinine), and conductivity (hematocrit) to provide quantitative measurements. Operated by healthcare professionals in clinical settings or central labs. Output displayed on touch screen; aids clinicians in diagnosing acid/base status, electrolyte, and metabolite balance. Device facilitates rapid point-of-care decision-making for life-threatening conditions.

Clinical Evidence

No clinical data provided. The submission relies on design control activities, risk analysis, and verification/validation testing to demonstrate that the operating system upgrade does not impact device performance or safety.

Technological Characteristics

Portable critical care analyzer; dimensions 18.5" x 13.1" x 16.3"; weight 42.1 lbs. Sensing principles: potentiometry, amperometry, conductivity. Connectivity: menu-driven touch screen. Software: Wind River LTS 18 Linux OS. Sterilization: N/A (in vitro diagnostic).

Indications for Use

Indicated for use by healthcare professionals in clinical settings for the in vitro measurement of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, creatinine, urea nitrogen, bicarbonate, and hematocrit in whole blood samples.

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

• GEM Premier ChemSTAT (K183549, K183546, K183555)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K223090

B Applicant

Instrumentation Laboratory Co.

C Proprietary and Established Names

GEM Premier ChemSTAT

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CGA | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |
| JGS | Class II | 21 CFR 862.1665 - Sodium test system | CH - Clinical Chemistry |
| CEM | Class II | 21 CFR 862.1600 - Potassium test system | CH - Clinical Chemistry |
| CGZ | Class II | 21 CFR 862.1170 - Chloride test system | CH - Clinical Chemistry |
| JFP | Class II | 21 CFR 862.1145 - Calcium test system | CH - Clinical Chemistry |
| CHL | Class II | 21 CFR 862.1120 - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph system | CH - Clinical Chemistry |
| KHP | Class I | 21 CFR 862.1450 - Lactic acid test system | CH - Clinical Chemistry |
| GKF | Class II | 21 CFR 864.5600 - Automated hematocrit instrument | HE - Hematology |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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| JFY | Class II | 21 CFR 862.1225 - Creatinine test system | CH - Clinical Chemistry |
| --- | --- | --- | --- |
| CDQ | Class II | 21 CFR 862.1770 - Urea nitrogen test system | CH - Clinical Chemistry |
| KHS | Class II | 21 CFR 862.1160 - Bicarbonate/carbon dioxide test system | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

The name and 510(k) number of the SUBMITTER'S previously cleared device. GEM Premier ChemSTAT, K183549, K183546 and K183555

1. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

2. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The device modification is an upgrade to the operating system of the instrument from Fedora 17 Linux to WindRiver LTS 18 Linux.

3. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

4. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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