Cleared Traditional

MYDAS(TM)-MB2/MYDAS(TM)-MB (K913380) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913380 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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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

Submission Details

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
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.

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 47
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