Cleared Traditional

K801299 - COBAS CK-NAC REAGENT

K801299 is an FDA 510(k) clearance for COBAS CK-NAC REAGENT, manufactured by Roche Analytical Instruments, Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K801299 · Roche Analytical Instruments, Inc. · Chemistry device
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Jul 1980
Decision
42d
Days
Class 2
Risk

K801299 is an FDA 510(k) clearance for the COBAS CK-NAC REAGENT. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Roche Analytical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 42 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 Roche Analytical Instruments, Inc. devices

FDA 510(k) Submission Details - K801299

510(k) Number K801299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1980
Decision Date July 14, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGS Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K801299.
CARDIOZYME PLUS CK-TOTAL ITEM #65046
K811574 · Harleco · Jun 1981
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
CHEM-STRATE CK-NAC
K792477 · General Diagnostics · Dec 1979
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · Sigma Chemical Co. · Dec 1978