Cleared Traditional

K771389 - CK-1 ULTRAZYME PLUS

K771389 is the FDA 510(k) clearance for CK-1 ULTRAZYME PLUS by Harleco. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K771389 · Harleco · Chemistry device
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Sep 1977
Decision
37d
Days
Class 2
Risk

K771389 is an FDA 510(k) clearance for the CK-1 ULTRAZYME PLUS. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 37 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 Harleco devices

Submission Details

510(k) Number K771389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1977
Decision Date September 02, 1977
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K771389.
STAC SYSTEM - ADDITIONAL ANALYTES
K772352 · Technicon Instruments Corp. · Jan 1978
CLINICARD CK-II
K772258 · Harleco · Jan 1978
CPK COLOR TEST KIT
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MULTISTAT III CPK TEST
K771441 · Instrumentation Laboratory CO · Aug 1977
DYNAZYME-II TM CK-230 KIT
K761344 · J.T. Baker Chemical Co. · Jan 1977