Cleared Traditional

COBAS CK-NAC REAGENT (K801299) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 46
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K801299.
PARAMAX CREATINE KINASE REAGENT
K831537 · American Dade · Jun 1983
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · Beckman Instruments, Inc. · May 1982
SERALYZER CK REAGENT STRIPS
K820880 · Miles Laboratories, Inc. · Apr 1982
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · Sigma Chemical Co. · Dec 1978
CPK-L TUBE
K781149 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
STAC SYSTEM - ADDITIONAL ANALYTES
K772352 · Technicon Instruments Corp. · Jan 1978