Cleared Traditional

K800127 - CENTRIFICHEM CK

K800127 is an FDA 510(k) clearance for CENTRIFICHEM CK, manufactured by Union Carbide Corp.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K800127 · Union Carbide Corp. · Chemistry device
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Feb 1980
Decision
26d
Days
Class 2
Risk

K800127 is an FDA 510(k) clearance for the CENTRIFICHEM CK. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 26 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K800127

510(k) Number K800127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 13, 1980
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 103
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K800127.
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
CHEM-STRATE CK-NAC
K792477 · General Diagnostics · Dec 1979
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