Cleared Traditional

K792477 - CHEM-STRATE CK-NAC

K792477 is the FDA 510(k) clearance for CHEM-STRATE CK-NAC by General Diagnostics. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K792477 · General Diagnostics · Chemistry device
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Dec 1979
Decision
24d
Days
Class 2
Risk

K792477 is an FDA 510(k) clearance for the CHEM-STRATE CK-NAC. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979 after a review of 24 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 General Diagnostics devices

Submission Details

510(k) Number K792477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date December 27, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 99
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K792477.
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
K811576 · Harleco · Jun 1981
CREATINE KINASE REAGENT
K803301 · Gilford Diagnostics · Jan 1981
CENTRIFICHEM CK
K800127 · Union Carbide Corp. · Feb 1980
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · Sigma Chemical Co. · Dec 1978
CPK REAGENT SET, NAD REDUCTION
K781719 · Medical Analysis Systems, Inc. · Nov 1978
CPK-L TUBE
K781149 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978