Cleared Traditional

K792533 - CREATINE PHOSPHOKINASE (CPK) REAGENT SET

K792533 is the FDA 510(k) clearance for CREATINE PHOSPHOKINASE (CPK) REAGENT SET by Macomb Chemical Co.. It is a Class 2 Chemistry device (product code JHW) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K792533 · Macomb Chemical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1980
Decision
35d
Days
Class 2
Risk

K792533 is an FDA 510(k) clearance for the CREATINE PHOSPHOKINASE (CPK) REAGENT SET. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 35 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K792533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1979
Decision Date January 11, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHW U.v. Method, Cpk 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.