Cleared Traditional

K813573 - CARDIOTRAC CORNING CK ISOENZYME SUBST

K813573 is an FDA 510(k) clearance for CARDIOTRAC CORNING CK ISOENZYME SUBST, manufactured by Corning Medical & Scientific. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K813573 · Corning Medical & Scientific · Chemistry device
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Jan 1982
Decision
27d
Days
Class 2
Risk

K813573 is an FDA 510(k) clearance for the CARDIOTRAC CORNING CK ISOENZYME SUBST. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 27 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 Corning Medical & Scientific devices

FDA 510(k) Submission Details - K813573

510(k) Number K813573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date January 18, 1982
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 41
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K813573.
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171 · American Dade · Sep 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
K870987 · Ciba Corning Diagnostics Corp. · May 1987
CK-B RIA KIT
K840549 · Diagnostic Systems Laboratories, Inc. · May 1984
ABURIA-CK RIA TEST KIT
K813087 · Intl. Immunoassay Laboratories, Inc. · Dec 1981
NML CK-MB RIA
K812759 · Nuclear Medical Laboratories, Inc. · Oct 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · Beckman Instruments, Inc. · Jan 1981