Cleared Traditional

K810853 - CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT

K810853 is the FDA 510(k) clearance for CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT by The Upjohn Co.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K810853 · The Upjohn Co. · Chemistry device
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May 1981
Decision
60d
Days
Class 2
Risk

K810853 is an FDA 510(k) clearance for the CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by The Upjohn Co. (Mchenry, US). The FDA issued a Cleared decision on May 29, 1981 after a review of 60 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 The Upjohn Co. devices

Submission Details

510(k) Number K810853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1981
Decision Date May 29, 1981
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 103
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K810853.
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
K812593 · Harleco · Oct 1981
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