Cleared Special

K223090 - GEM Premier ChemSTAT (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223090 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (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.

View all Instrumentation Laboratory CO devices

Submission Details

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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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