Cleared Traditional

K771441 - MULTISTAT III CPK TEST

K771441 is an FDA 510(k) clearance for MULTISTAT III CPK TEST, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K771441 · Instrumentation Laboratory CO · Chemistry device
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Aug 1977
Decision
21d
Days
Class 2
Risk

K771441 is an FDA 510(k) clearance for the MULTISTAT III CPK TEST. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977 after a review of 21 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K771441

510(k) Number K771441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date August 22, 1977
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 117
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K771441.
CLINICARD CK-II
K772258 · Harleco · Jan 1978
CPK COLOR TEST KIT
K771849 · Mallinckrodt Critical Care · Nov 1977
CK-1 ULTRAZYME PLUS
K771389 · Harleco · Sep 1977
CPK ULTRAZYME PLUS
K770694 · Harleco Diagnostics · Jul 1977
REAGENT CPK, ENZYME
K770319 · Icn Pharmaceuticals, Inc. · Apr 1977
DYNAZYME-II TM CK-230 KIT
K761344 · J.T. Baker Chemical Co. · Jan 1977