Cleared Traditional

K112995 - GEM PREMIER 4000

K112995 is the FDA 510(k) clearance for GEM PREMIER 4000 by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K112995 · Instrumentation Laboratory CO · Chemistry device
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Optimized for regulatory review, auditing and printing
May 2012
Decision
209d
Days
Class 2
Risk

K112995 is an FDA 510(k) clearance for the GEM PREMIER 4000. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Orangeburg, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 209 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K112995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2011
Decision Date May 03, 2012
Days to Decision 209 days
Submission Type Traditional
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
121d slower than avg
Panel avg: 88d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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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All 42
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