Cleared Traditional

K914361 - CREATINE KINASE MB TEST ITEM NUMBER 5A46

K914361 is the FDA 510(k) clearance for CREATINE KINASE MB TEST ITEM NUMBER 5A46 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K914361 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1991
Decision
73d
Days
Class 2
Risk

K914361 is an FDA 510(k) clearance for the CREATINE KINASE MB TEST ITEM NUMBER 5A46. 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 December 13, 1991 after a review of 73 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K914361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date December 13, 1991
Days to Decision 73 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 faster than avg
Panel avg: 88d · This submission: 73d
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 K914361.
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