Cleared Traditional

K913298 - AIA-PACK CK-MB

K913298 is an FDA 510(k) clearance for AIA-PACK CK-MB, manufactured by Tosoh Corp.. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K913298 · Tosoh Corp. · Chemistry device
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Sep 1991
Decision
64d
Days
Class 2
Risk

K913298 is an FDA 510(k) clearance for the AIA-PACK CK-MB. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Tosoh Corp. (Washington, D.C., US). The FDA issued a Cleared decision on September 27, 1991 after a review of 64 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 Tosoh Corp. devices

FDA 510(k) Submission Details - K913298

510(k) Number K913298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date September 27, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 K913298.
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K972782 · Dade Intl., Inc. · Aug 1997
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · Biomerieux Vitek, Inc. · Aug 1996
MYDAS(TM)-MB2/MYDAS(TM)-MB
K913380 · Intl. Immunoassay Laboratories, Inc. · Apr 1992
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121 · Ciba Corning Diagnostics Corp. · Apr 1991
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
K903441 · Intl. Immunoassay Laboratories, Inc. · Nov 1990
IMPRES-MB REAGENT A AND REAGENT B
K890543 · Intl. Immunoassay Laboratories, Inc. · Mar 1989