Cleared Traditional

Aptiva Celiac Disease IgG Reagent

K200230 · Inova Diagnostics, Inc. · Immunology
Aug 2021
Decision
574d
Days
Class 2
Risk

About This 510(k) Submission

K200230 is an FDA 510(k) clearance for the Aptiva Celiac Disease IgG Reagent, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 26, 2021, 574 days after receiving the submission on January 30, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K200230 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2020
Decision Date August 26, 2021
Days to Decision 574 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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 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
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K183313 · Euroimmun Us, Inc. · Feb 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