Cleared Special

K223090 - GEM Premier ChemSTAT

K223090 is an FDA 510(k) clearance for GEM Premier ChemSTAT, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 119-day FDA review.

K223090 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
119d
Days
Class 2
Risk

K223090 is an FDA 510(k) clearance for the GEM Premier ChemSTAT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 27, 2023 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K223090

510(k) Number K223090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date January 27, 2023
Days to Decision 119 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 89d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K223090.
Cholestech LDX ™ System
K223179 · Alere San Diego, Inc. · Sep 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · Abbott Point of Care, Inc. · Sep 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · Abbott Point of Care, Inc. · Jul 2023
Nova Primary Glucose Analyzer System
K203549 · Nova Biomedical Corporation · Oct 2022
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · Abbott Point of Care, Inc. · Aug 2021
Stat Profile Prime Plus Analyzer System
K200349 · Nova Biomedical Corporation · Mar 2020
K223090 · GEM Premier ChemSTAT
Download PDF FDA Summary Instrumentation Labor…