Cleared Traditional

CREATINE KINASE ISOENZYME SUBSTRATE SET (K771605) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771605 · Pfizer Pharmaceuticals · Chemistry device
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Sep 1977
Decision
24d
Days
Class 2
Risk

K771605 is an FDA 510(k) clearance for the CREATINE KINASE ISOENZYME SUBSTRATE SET. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Pfizer Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on September 15, 1977 after a review of 24 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 Pfizer Pharmaceuticals devices

Submission Details

510(k) Number K771605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1977
Decision Date September 15, 1977
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHX Fluorometric 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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 17
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K771605.
TITAN GEL CPK REP SYSTEM
K873399 · Helena Laboratories · Oct 1987
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · Beckman Instruments, Inc. · Jan 1981
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · Helena Laboratories · Jul 1980
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
K760591 · Sigma Chemical Co. · Oct 1976