Cleared Traditional

K791582 - CARDIO CK-B RIA KIT

K791582 is the FDA 510(k) clearance for CARDIO CK-B RIA KIT by Nuclear Medical Systems, Inc.. It is a Class 2 Chemistry device (product code JHX) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K791582 · Nuclear Medical Systems, Inc. · Chemistry device
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Nov 1979
Decision
92d
Days
Class 2
Risk

K791582 is an FDA 510(k) clearance for the CARDIO CK-B RIA KIT. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Nuclear Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1979 after a review of 92 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 Nuclear Medical Systems, Inc. devices

Submission Details

510(k) Number K791582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1979
Decision Date November 15, 1979
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K791582.
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · Helena Laboratories · Jul 1980
CORNING TRANSPHOR
K800544 · Corning Medical & Scientific · Mar 1980
RIA-QUANT CK-MB TEST KIT
K792504 · Mallinckrodt Critical Care · Jan 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