Cleared Traditional

K913380 - MYDAS(TM)-MB2/MYDAS(TM)-MB

K913380 is an FDA 510(k) clearance for MYDAS(TM)-MB2/MYDAS(TM)-MB, manufactured by Intl. Immunoassay Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K913380 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
268d
Days
Class 2
Risk

K913380 is an FDA 510(k) clearance for the MYDAS(TM)-MB2/MYDAS(TM)-MB. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 268 days - an extended review 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: 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 Intl. Immunoassay Laboratories, Inc. devices

FDA 510(k) Submission Details - K913380

510(k) Number K913380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date April 22, 1992
Days to Decision 268 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 88d · This submission: 268d
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 K913380.
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
K973126 · Biosite Incorporated · Oct 1997
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
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