Cleared Traditional

K002107 - IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.

K002107 is an FDA 510(k) clearance for IFA KIT FOR THE DETECTION OF ENDOMYSIAL..., 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 23-day FDA review.

K002107 · Scimedx Corp. · Immunology device
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Aug 2000
Decision
23d
Days
Class 2
Risk

K002107 is an FDA 510(k) clearance for the IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL.... Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 23 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 - K002107

510(k) Number K002107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2000
Decision Date August 04, 2000
Days to Decision 23 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
82d faster than avg
Panel avg: 105d · This submission: 23d
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 K002107.
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