Cleared Traditional

K924832 - OLYMPUS CREATINE KINASE REAGENT

K924832 is an FDA 510(k) clearance for OLYMPUS CREATINE KINASE REAGENT, manufactured by Olympus Corp.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K924832 · Olympus Corp. · Chemistry device
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Jan 1993
Decision
101d
Days
Class 2
Risk

K924832 is an FDA 510(k) clearance for the OLYMPUS CREATINE KINASE REAGENT. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on January 4, 1993 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Corp. devices

FDA 510(k) Submission Details - K924832

510(k) Number K924832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1992
Decision Date January 04, 1993
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K924832.
KING DIAGNOSTICS CK REAGENT
K931326 · King Diagnostics, Inc. · Jun 1993
SYNERMED CREATINE KINASE REAGENT KIT
K930932 · Synermed, Inc. · May 1993
CREATINE KINASE (CK) REAGENT SET
K930660 · Pointe Scientific, Inc., · Mar 1993
REP E-Z CK-30 ISOENZYME KIT
K925801 · Helena Laboratories · Dec 1992
CK-NAC ACTIVATED KIT
K923511 · Randox Laboratories, Ltd. · Oct 1992
CREATINE KINASE (CK) TEST ITEM #65411
K924704 · Em Diagnostic Systems, Inc. · Oct 1992