Cleared Traditional

K821464 - CARDIOZYME PLUS CK-MB

K821464 is the FDA 510(k) clearance for CARDIOZYME PLUS CK-MB by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821464 · Emd Chemicals, Inc. · Chemistry device
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Jun 1982
Decision
15d
Days
Class 2
Risk

K821464 is an FDA 510(k) clearance for the CARDIOZYME PLUS CK-MB, #65045. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 15 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K821464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 02, 1982
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K821464.
CREATINE KINASE REAGENT CK LTS
K831965 · Electro-Nucleonics Laboratories, Inc. · Sep 1983
PARAMAX CREATINE KINASE REAGENT
K831537 · American Dade · Jun 1983
ULTRAZYME PLUS CKI, #64978,65027&65028
K821473 · Emd Chemicals, Inc. · Jun 1982
ULTRAZYME PLUS CK-I, #64978,65027&65028
K821460 · Emd Chemicals, Inc. · Jun 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · Beckman Instruments, Inc. · May 1982
SERALYZER CK REAGENT STRIPS
K820880 · Miles Laboratories, Inc. · Apr 1982