Cleared Traditional

K792504 - RIA-QUANT CK-MB TEST KIT

K792504 is an FDA 510(k) clearance for RIA-QUANT CK-MB TEST KIT, manufactured by Mallinckrodt Critical Care. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K792504 · Mallinckrodt Critical Care · Chemistry device
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Jan 1980
Decision
43d
Days
Class 2
Risk

K792504 is an FDA 510(k) clearance for the RIA-QUANT CK-MB TEST KIT. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980 after a review of 43 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 Mallinckrodt Critical Care devices

FDA 510(k) Submission Details - K792504

510(k) Number K792504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1979
Decision Date January 16, 1980
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

Product Code JHX Fluorometric Method, 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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 42
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K792504.
EMBRIA-CK
K801728 · Intl. Immunoassay Laboratories, Inc. · Sep 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · Helena Laboratories · Jul 1980
CORNING TRANSPHOR
K800544 · Corning Medical & Scientific · Mar 1980
BUFFER, CORNING MOPSO
K790294 · Corning Medical & Scientific · Mar 1979
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
K771324 · Corning Medical & Scientific · Sep 1977
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
K760591 · Sigma Chemical Co. · Oct 1976