Cleared Traditional

K183313 - EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

K183313 is an FDA 510(k) clearance for EUROIMMUN Anti-tissue Transglutaminase ..., manufactured by Euroimmun Us, Inc.. The device is a Class 2 Immunology device with product code MVM cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K183313 · Euroimmun Us, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
91d
Days
Class 2
Risk

K183313 is an FDA 510(k) clearance for the EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Tra.... Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on February 28, 2019 after a review of 91 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, Inc. devices

FDA 510(k) Submission Details - K183313

510(k) Number K183313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 105d · This submission: 91d
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 32
Devices cleared under the same product code (MVM) and FDA review panel - the closest regulatory comparables to K183313.
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
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