Cleared Traditional

K952646 - IL TEST CK-MB

K952646 is the FDA 510(k) clearance for IL TEST CK-MB by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K952646 · Instrumentation Laboratory CO · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
56d
Days
Class 2
Risk

K952646 is an FDA 510(k) clearance for the IL TEST CK-MB. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 4, 1995 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K952646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date August 04, 1995
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 85
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K952646.
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
K973999 · Diagnostic Chemicals , Ltd. · Mar 1998
CK-MB (NAC-ACT)
K951223 · Randox Laboratories, Ltd. · Dec 1995
CREATINE KINASE REAGENT SYSTEM
K952745 · Medical Diagnostic Technologies, Inc. · Aug 1995
CK-MB ASSAY, CATALOGUE NUMBER 317-10
K942773 · Diagnostic Chemicals , Ltd. · Aug 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463 · Pointe Scientific, Inc., · Jan 1994
CREATINE KINASE TEST
K931889 · Em Diagnostic Systems, Inc. · Jul 1993