Cleared Traditional

K061408 - EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

K061408 is an FDA 510(k) clearance for EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MO..., manufactured by Euroimmun Us, LLC. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 136-day FDA review.

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

FDA 510(k) Submission Details - K061408

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
31d slower than avg
Panel avg: 105d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVM Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K061408.
QUANTA PLEX CELIAC IGA PROFILE
K063818 · Inova Diagnostics, Inc. · Jun 2007
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · Phadia US, Inc. · Dec 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · Phadia US, Inc. · Dec 2006
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · Immco Diagnostics, Inc. · May 2006
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
K040095 · Immco Diagnostics, Inc. · Mar 2004
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571 · Immco Diagnostics, Inc. · Dec 2003