MVM · Autoantibodies, Endomysial(Tissue Transglutaminase)
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | MVM |
|---|---|
| Device Name | Autoantibodies, Endomysial(Tissue Transglutaminase) |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200230 | Aptiva Celiac Disease IgG Reagent | Inova Diagnostics, Inc. | Aug 26, 2021 | SESE |
| K193604 | Aptiva Celiac Disease IgA Reagent | Inova Diagnostics, Inc. | Jun 16, 2021 | SESE |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Phadia AB | Mar 1, 2019 | SESE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | Euroimmun Us, Inc. | Feb 28, 2019 | SESE |
| K140691 | IG_PLEX CELIAC DGP PANEL | Sqi Diagnostics Systems, Inc. | Nov 6, 2014 | SESE |
| K123713 | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | Oct 25, 2013 | SESE |
| K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | Bio-Rad Laboratories, Inc. | Sep 19, 2013 | SESE |
| K102490 | IGX PLEX CELIAC QUALITATIVE ASSAY | Sqi Diagnostics Systems | Jun 2, 2011 | SESE |
| K101644 | QUANTA FLASH H-TTG IGG | Inova Diagnostics, Inc. | Mar 23, 2011 | SESE |
| K102964 | EU-TTG IGA AND EU-TTG IGG | Grifols USA, Inc. | Mar 7, 2011 | SESE |
| K094060 | QUANTA FLASH H-TTG IGA | Inova Diagnostics, Inc. | Oct 13, 2010 | SESE |
| K091520 | IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | Mar 10, 2010 | SESE |
| K073145 | QUANTA LITE H-TTG SCREEN | Inova Diagnostics, Inc. | Feb 12, 2008 | SESE |
| K072632 | QUANTA PLEX CELIAC IGG PROFILE | Inova Diagnostics, Inc. | Feb 11, 2008 | SESE |
| K072967 | QUANTA LITE F-ACTIN IGA ELISA | Inova Diagnostics, Inc. | Jan 28, 2008 | SESE |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS | Theratest Laboratories, Inc. | Nov 5, 2007 | SESE |
| K063818 | QUANTA PLEX CELIAC IGA PROFILE | Inova Diagnostics, Inc. | Jun 20, 2007 | SESE |
| K062787 | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 | Phadia US, Inc. | Dec 29, 2006 | SESE |
| K062583 | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 | Phadia US, Inc. | Dec 26, 2006 | SESE |
| K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT | Euroimmun Us, LLC | Oct 5, 2006 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 12 clearances
- Immco Diagnostics, Inc. — 6 clearances
- Scimedx Corp. — 3 clearances
- The Binding Site, Ltd. — 2 clearances
- Sweden Diagnostics (Germany) GmbH — 2 clearances
