Cleared Traditional

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT (K061408) - FDA 510(k) Clearance

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

K061408 · Euroimmun Us, LLC · Immunology device
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Oct 2006
Decision
136d
Days
Class 2
Risk

K061408 is an FDA 510(k) clearance for the EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Euroimmun Us, LLC (Boonton Township, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Euroimmun Us, LLC devices

Submission Details

510(k) Number K061408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2006
Decision Date October 05, 2006
Days to Decision 136 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
32d slower than avg
Panel avg: 104d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVM Autoantibodies, Endomysial(tissue Transglutaminase)
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.

Regulatory Peers - MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 39
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K061408.
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EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K183313 · Euroimmun Us, Inc. · Feb 2019