Cleared Traditional

K874284 - SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-M...

K874284 is the FDA 510(k) clearance for SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-M... by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code JHT) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K874284 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jan 1988
Decision
99d
Days
Class 2
Risk

K874284 is an FDA 510(k) clearance for the SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on January 21, 1988 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K874284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date January 21, 1988
Days to Decision 99 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
11d slower than avg
Panel avg: 88d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHT Chromatographic Separation, 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 - JHT Chromatographic Separation, Cpk Isoenzymes

All 11
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K874284.
COULTER CK-MB ISOENZYME REAGENT
K904866 · Coulter Electronics, Inc. · Dec 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · Helena Laboratories · Feb 1990
CREATINE KINASE (CK) ISOENZYME MB
K881168 · Data Medical Associates, Inc. · Nov 1988
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
K872041 · Coulter Electronics, Inc. · Sep 1987
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · Helena Laboratories · Nov 1982
CPK-CS
K790357 · Hoffmann-La Roche, Inc. · Apr 1979