Cleared Traditional

K994189 - OLYMPUS CREATINE KINASE REAGENT OSR6179/6279

K994189 is an FDA 510(k) clearance for OLYMPUS CREATINE KINASE REAGENT OSR6179..., manufactured by Olympus Diagnostica GmbH. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K994189 · Olympus Diagnostica GmbH · Chemistry device
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Jan 2000
Decision
38d
Days
Class 2
Risk

K994189 is an FDA 510(k) clearance for the OLYMPUS CREATINE KINASE REAGENT OSR6179/6279. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Olympus Diagnostica GmbH (Melville, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 38 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 Olympus Diagnostica GmbH devices

FDA 510(k) Submission Details - K994189

510(k) Number K994189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date January 20, 2000
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K994189.
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202 · Olympus America, Inc. · Dec 2004
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
K021332 · Wiener Laboratories Saic · Jul 2002
CREATINE KINASE (CK-NAC)
K013912 · Jas Diagnostics, Inc. · Jan 2002
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
K992148 · Morax · Dec 1999
CK
K983070 · Abbott Laboratories · Feb 1999
CREATINE KINASE (CK)
K981218 · Abbott Laboratories · May 1998