Cleared Traditional

K915709 - CREATINE KINASE-MB (CK-MB) REAGENT SET

K915709 is an FDA 510(k) clearance for CREATINE KINASE-MB (CK-MB) REAGENT SET, manufactured by Tech Intl. Co.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K915709 · Tech Intl. Co. · Chemistry device
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Jan 1992
Decision
59d
Days
Class 2
Risk

K915709 is an FDA 510(k) clearance for the CREATINE KINASE-MB (CK-MB) REAGENT SET. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 59 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 Tech Intl. Co. devices

FDA 510(k) Submission Details - K915709

510(k) Number K915709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date January 27, 1992
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
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 118
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K915709.
CK-NAC ACTIVATED KIT
K923511 · Randox Laboratories, Ltd. · Oct 1992
CREATINE KINASE (CK) TEST ITEM #65411
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K922459 · Olympus Corp. · Jul 1992
CREATINE KINASE MB TEST ITEM NUMBER 5A46
K914361 · Em Diagnostic Systems, Inc. · Dec 1991
RAICHEM(TM) CREATINE KINASE-MB REAGENT
K913398 · Reagents Applications, Inc. · Sep 1991
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
K905084 · Reagents Applications, Inc. · Dec 1990