Cleared Traditional

K010625 - EUROSPITAL EU-TTG IGA UMANA

K010625 is an FDA 510(k) clearance for EUROSPITAL EU-TTG IGA UMANA, manufactured by Scimedx Corp.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K010625 · Scimedx Corp. · Immunology device
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Apr 2001
Decision
53d
Days
Class 2
Risk

K010625 is an FDA 510(k) clearance for the EUROSPITAL EU-TTG IGA UMANA. Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Scimedx Corp. (Denville, US). The FDA issued a Cleared decision on April 24, 2001 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scimedx Corp. devices

FDA 510(k) Submission Details - K010625

510(k) Number K010625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date April 24, 2001
Days to Decision 53 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
52d faster than avg
Panel avg: 105d · This submission: 53d
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 31
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K010625.
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
K032571 · Immco Diagnostics, Inc. · Dec 2003
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
K011566 · Inova Diagnostics, Inc. · Jul 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · Inova Diagnostics, Inc. · Jul 2001
EU-TTG IGA ELISA
K994379 · Scimedx Corp. · Feb 2000
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612 · The Binding Site, Ltd. · Dec 1999
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD
K993034 · Medica, Inc. · Nov 1999