Cleared Traditional

K761212 - CPK1SOENZYMES DETERMINATION PRO. #715-EP

K761212 is an FDA 510(k) clearance for CPK1SOENZYMES DETERMINATION PRO. #715-EP, manufactured by Sigma Chemical Co.. The device is a Class 2 Chemistry device with product code JHY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K761212 · Sigma Chemical Co. · Chemistry device
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Dec 1976
Decision
14d
Days
Class 2
Risk

K761212 is an FDA 510(k) clearance for the CPK1SOENZYMES DETERMINATION PRO. #715-EP. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on December 21, 1976 after a review of 14 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K761212

510(k) Number K761212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1976
Decision Date December 21, 1976
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHY Device Classification - Class 2, Special Controls

Product Code JHY Colorimetric Method, 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 - JHY Colorimetric Method, Cpk Or Isoenzymes

All 36
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K761212.
CREATINE KINASE-MB KIT
K820812 · Calbiochem-Behring Corp. · Apr 1982
REAGENT FOR DETERM. CREATINE PHOSPHOKINA
K800684 · Diagnostic Solutions, Inc. · May 1980
CPK ISOENZYME REAGENT
K791655 · Electrophoresis Corp. of America · Sep 1979
LANCER MB/CPK ISOENZYME KIT
K760871 · Sherwood Medical Industries · Nov 1976