GEM Premier 5000

K203790 · Instrumentation Laboratory CO · CHL · Aug 20, 2021 · Clinical Chemistry

Device Facts

• Record ID: K203790
• Device Name: GEM Premier 5000
• Applicant: Instrumentation Laboratory CO
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 20, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The GEM Premier 5000 is a portable, automated blood gas/electrolyte/metabolite/co-oximetry analyzer system intended for use by healthcare professionals in a clinical laboratory setting or at the point-of-care. It is intended for the in vitro diagnostic measurement of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, total bilirubin, hematocrit, total hemoglobin, and hemoglobin fractions (O2Hb, COHb, MetHb, HHb) in whole blood samples.

Device Story

Portable critical care system; analyzes heparinized whole blood samples via aspiration. Inputs: arterial, venous, or capillary blood. Principle of operation: potentiometry (pH, pCO2, Na+, K+, Cl-, Ca++), amperometry (pO2, glucose, lactate), spectrophotometry (CO-Oximetry, total bilirubin), and conductivity (hematocrit). Device processes signals to provide quantitative measurements and derived parameters. Used in clinical settings and central laboratories by healthcare professionals. Output displayed on menu-driven touch screen; aids diagnosis of acid-base disturbances, electrolyte/metabolite imbalances, and oxygen delivery capacity. Benefits: rapid point-of-care diagnostic information for critical care decision-making.

Clinical Evidence

No clinical data. Bench testing only. Software verification was performed to validate the operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux in accordance with FDA guidance on software validation and cybersecurity.

Technological Characteristics

Portable system (18.6 x 13.0 x 16.4 inches, 45.4 lbs). Sensing principles: potentiometry (pH, pCO2, Na+, K+, Cl-, Ca++), amperometry (pO2, glucose, lactate), spectrophotometry (CO-Oximetry, total bilirubin), conductivity (hematocrit). User interface: menu-driven touch screen. Operating system: WindRiver LTS 18 Linux. Sample introduction: aspiration. Operating temperature: 12-32°C.

Indications for Use

Indicated for use by healthcare professionals in clinical or point-of-care settings for the in vitro diagnostic measurement of blood gases, electrolytes, metabolites, and co-oximetry parameters in whole blood samples.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• GEM Premier 5000 (K173403)
• GEM Premier 5000 (K160415)
• GEM Premier 5000 (K160402)
• GEM Premier 5000 (K160225)

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

K203790

B Applicant

Instrumentation Laboratory Co.

C Proprietary and Established Names

GEM Premier 5000

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHL | Class II | 21 CFR 862.1120 - Blood Gases (pCO2, pO2) And Blood pH 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 |
| CGA | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |
| KHP | Class I | 21 CFR 862.1450 - Lactic acid test system | CH - Clinical Chemistry |
| MQM | Class I, reserved | 21 CFR 862.1113 - Bilirubin (total and unbound) in the neonate 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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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GHS | Class II | 21 CFR 864.7425 - Carboxyhemoglobin assay | HE - Hematology |
| GKR | Class II | 21 CFR 864.5620 - Automated hemoglobin system | HE - Hematology |
| GLY | Class II | 21 CFR 864.7500 - Whole blood hemoglobin assays | HE - Hematology |

## 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.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device, the GEM Premier 5000, K173403, K160415, K160402, and K160225.

2. 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).

3. 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. This change was for the upgrade of the operating system from Fedora 17 Linux to WindRiver LTS 18 Linux for the instrument.

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

5. 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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