Cleared Traditional

K912551 - ANTI-ENDOMYSIAL ANTIBODY TEST (FDA 510(k) Clearance)

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

K912551 · Immco Diagnostics, Inc. · Immunology device
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Jun 1993
Decision
729d
Days
Class 2
Risk

K912551 is an FDA 510(k) clearance for the ANTI-ENDOMYSIAL ANTIBODY TEST. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 729 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Immco Diagnostics, Inc. devices

Submission Details

510(k) Number K912551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1991
Decision Date June 09, 1993
Days to Decision 729 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
625d slower than avg
Panel avg: 104d · This submission: 729d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 Immunology devices follow this clearance model.