Cleared Traditional

K883504 - DURAZYME CPK

K883504 is the FDA 510(k) clearance for DURAZYME CPK by American Monitor Corp.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K883504 · American Monitor Corp. · Chemistry device
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Sep 1988
Decision
27d
Days
Class 2
Risk

K883504 is an FDA 510(k) clearance for the DURAZYME(R) CPK. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 27 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 American Monitor Corp. devices

Submission Details

510(k) Number K883504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1988
Decision Date September 13, 1988
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K883504.
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547 · Em Diagnostic Systems, Inc. · Feb 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
K884546 · Em Diagnostic Systems, Inc. · Feb 1989
VISION CREATINE KINASE
K883946 · Abbott Laboratories · Oct 1988
WAKO(TM) AUTOKIT CK-NAC
K873201 · Wako Chemicals USA, Inc. · Nov 1987
TITAN GEL REP CPK-12 HV
K874146 · Helena Laboratories · Nov 1987
TITAN GEL REP CPK-30 HV
K874139 · Helena Laboratories · Nov 1987