Cleared Traditional

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

K183313 · Euroimmun Us, Inc. · Immunology
Feb 2019
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K183313 is an FDA 510(k) clearance for the EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG), a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on February 28, 2019, 91 days after receiving the submission on November 29, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K183313 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2018
Decision Date February 28, 2019
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MVM — Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

Similar Devices — MVM Autoantibodies, Endomysial(tissue Transglutaminase)

All 39
Aptiva Celiac Disease IgG Reagent
K200230 · Inova Diagnostics, Inc. · Aug 2021
Aptiva Celiac Disease IgA Reagent
K193604 · Inova Diagnostics, Inc. · Jun 2021
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
K181871 · Phadia AB · Mar 2019
IG_PLEX CELIAC DGP PANEL
K140691 · Sqi Diagnostics Systems, Inc. · Nov 2014
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · Immco Diagnostics, Inc. · Oct 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
K130053 · Bio-Rad Laboratories, Inc. · Sep 2013