Cleared Traditional

K782015 - A-GENT CK-MB

K782015 is an FDA 510(k) clearance for A-GENT CK-MB, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K782015 · Abbott Laboratories · Chemistry device
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Feb 1979
Decision
58d
Days
Class 2
Risk

K782015 is an FDA 510(k) clearance for the A-GENT CK-MB. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 1, 1979 after a review of 58 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K782015

510(k) Number K782015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date February 01, 1979
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHW Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K782015.
CREATINE KINASE MB ISOENZYME IMMUNO UV
K810861 · The Dow Chemical Co. · Apr 1981
ISOMUNE-CK
K810905 · Hoffmann-La Roche, Inc. · Apr 1981
CARDIO ZYME PLUS CK-MB #65045
K803168 · Harleco · Jan 1981
CPK ISOENZYME REAGENT
K781124 · Electrophoresis Corp. of America · Aug 1978
DYNAZYME TM II CARDIAK-MB
K772172 · J.T. Baker Chemical Co. · Dec 1977