Cleared Special

K161818 - GEM Premier 3000

K161818 is an FDA 510(k) clearance for GEM Premier 3000, 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 75-day FDA review.

K161818 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
75d
Days
Class 2
Risk

K161818 is an FDA 510(k) clearance for the GEM Premier 3000. 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 September 14, 2016 after a review of 75 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K161818

510(k) Number K161818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date September 14, 2016
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
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 373
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K161818.
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K161818 · GEM Premier 3000
Download PDF FDA Summary Instrumentation Labor…