Cleared Traditional

K872592 - IMACK-MB(TM)

K872592 is the FDA 510(k) clearance for IMACK-MB(TM) by Intl. Immunoassay Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHT) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K872592 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Jul 1987
Decision
30d
Days
Class 2
Risk

K872592 is an FDA 510(k) clearance for the IMACK-MB(TM). Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 30 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 Intl. Immunoassay Laboratories, Inc. devices

Submission Details

510(k) Number K872592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1987
Decision Date July 31, 1987
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 12
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K872592.
CREATINE KINASE (CK) ISOENZYME MB
K881168 · Data Medical Associates, Inc. · Nov 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
K874284 · Diagnostic Chemicals, Ltd. (Usa) · Jan 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
CK-MB
K771497 · Boehringer Mannheim Corp. · Aug 1977