Cleared Traditional

K931889 - CREATINE KINASE TEST

K931889 is an FDA 510(k) clearance for CREATINE KINASE TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K931889 · Em Diagnostic Systems, Inc. · Chemistry device
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Jul 1993
Decision
103d
Days
Class 2
Risk

K931889 is an FDA 510(k) clearance for the CREATINE KINASE TEST. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 103 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K931889

510(k) Number K931889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1993
Decision Date July 27, 1993
Days to Decision 103 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
15d slower than avg
Panel avg: 88d · This submission: 103d
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 K931889.
CK-MB ASSAY, CATALOGUE NUMBER 317-10
K942773 · Diagnostic Chemicals , Ltd. · Aug 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463 · Pointe Scientific, Inc., · Jan 1994
OPUS TOTAL CK
K933675 · Pb Diagnostic Systems, Inc. · Sep 1993
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