Cleared Traditional

K810861 - CREATINE KINASE MB ISOENZYME IMMUNO UV

K810861 is the FDA 510(k) clearance for CREATINE KINASE MB ISOENZYME IMMUNO UV by The Dow Chemical Co.. It is a Class 2 Chemistry device (product code JHW) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810861 · The Dow Chemical Co. · Chemistry device
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Apr 1981
Decision
14d
Days
Class 2
Risk

K810861 is an FDA 510(k) clearance for the CREATINE KINASE MB ISOENZYME IMMUNO UV. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 14 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 The Dow Chemical Co. devices

Submission Details

510(k) Number K810861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1981
Decision Date April 14, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHW U.v. Method, Cpk 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 - JHW U.v. Method, Cpk Isoenzymes

All 13
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K810861.
DSL 1700
K822897 · Diagnostic Systems Laboratories, Inc. · Dec 1982
CARDIOZYME PLUS CK-MB ITEM #65045
K811573 · Harleco · Jun 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575 · Harleco · Jun 1981
ISOMUNE-CK
K810905 · Hoffmann-La Roche, Inc. · Apr 1981
CARDIO ZYME PLUS CK-MB #65045
K803168 · Harleco · Jan 1981
A-GENT CK-MB
K782015 · Abbott Laboratories · Feb 1979