Product Code: MVM FDA class 2 21 CFR 866.5660

Autoantibodies, Endomysial(Tissue Transglutaminase)

Immunology

An Endomysial/Tissue Transglutaminase Autoantibody Test is an immunological in vitro diagnostic device that detects autoantibodies against endomysial antigens or tissue transglutaminase in serum, used as a highly specific serological marker for the diagnosis of celiac disease and dermatitis herpetiformis. It is FDA Class 2, requiring 510(k) clearance, with product code MVM under 21 CFR 866.5660 in the Immunology specialty. The device is not an implant and is not life-sustaining.

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Basic Information

Product Code: MVM
Device Class: FDA class 2
Regulation Number: 866.5660
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K200230	Aptiva Celiac Disease IgG Reagent	Aug 26, 2021	Substantially Equivalent	Inova Diagnostics, Inc.
K193604	Aptiva Celiac Disease IgA Reagent	Jun 16, 2021	Substantially Equivalent	Inova Diagnostics, Inc.
K181871	EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay	Mar 01, 2019	Substantially Equivalent	Phadia AB
K183313	EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)	Feb 28, 2019	Substantially Equivalent	Euroimmun Us, Inc.
K140691	IG_PLEX CELIAC DGP PANEL	Nov 06, 2014	Substantially Equivalent	Sqi Diagnostics Systems, Inc.
K123713	IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA	Oct 25, 2013	Substantially Equivalent	Immco Diagnostics, Inc.
K130053	BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI	Sep 19, 2013	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K102490	IGX PLEX CELIAC QUALITATIVE ASSAY	Jun 02, 2011	Substantially Equivalent	Sqi Diagnostics Systems
K101644	QUANTA FLASH H-TTG IGG	Mar 23, 2011	Substantially Equivalent	Inova Diagnostics, Inc.
K102964	EU-TTG IGA AND EU-TTG IGG	Mar 07, 2011	Substantially Equivalent	Grifols USA, Inc.
K094060	QUANTA FLASH H-TTG IGA	Oct 13, 2010	Substantially Equivalent	Inova Diagnostics, Inc.
K091520	IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA	Mar 10, 2010	Substantially Equivalent	Immco Diagnostics, Inc.
K073145	QUANTA LITE H-TTG SCREEN	Feb 12, 2008	Substantially Equivalent	Inova Diagnostics, Inc.
K072632	QUANTA PLEX CELIAC IGG PROFILE	Feb 11, 2008	Substantially Equivalent	Inova Diagnostics, Inc.
K072967	QUANTA LITE F-ACTIN IGA ELISA	Jan 28, 2008	Substantially Equivalent	Inova Diagnostics, Inc.
K071692	THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS	Nov 05, 2007	Substantially Equivalent	Theratest Laboratories, Inc.
K063818	QUANTA PLEX CELIAC IGA PROFILE	Jun 20, 2007	Substantially Equivalent	Inova Diagnostics, Inc.
K062787	ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01	Dec 29, 2006	Substantially Equivalent	Phadia US, Inc.
K062583	ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01	Dec 26, 2006	Substantially Equivalent	Phadia US, Inc.
K061408	EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT	Oct 05, 2006	Substantially Equivalent	Euroimmun Us, LLC
K060157	IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA	May 25, 2006	Substantially Equivalent	Immco Diagnostics, Inc.
K042644	AESKULISA TTG A AND AESKULISA TTG G	Jun 01, 2005	Substantially Equivalent	Aesku, Inc.
K043433	AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA	Mar 07, 2005	Substantially Equivalent	Hycor Biomedical , Ltd.
K041173	CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996	Aug 02, 2004	Substantially Equivalent	Sweden Diagnostics (Germany) GmbH
K041174	CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196	Jul 19, 2004	Substantially Equivalent	Sweden Diagnostics (Germany) GmbH
K040466	BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS	Jul 16, 2004	Substantially Equivalent	The Binding Site
K040095	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA	Mar 05, 2004	Substantially Equivalent	Immco Diagnostics, Inc.
K033744	AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA	Jan 20, 2004	Substantially Equivalent	Hycor Biomedical , Ltd.
K032571	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA	Dec 24, 2003	Substantially Equivalent	Immco Diagnostics, Inc.
K011570	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA	Jul 09, 2001	Substantially Equivalent	Inova Diagnostics, Inc.
K011566	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA	Jul 09, 2001	Substantially Equivalent	Inova Diagnostics, Inc.
K010625	EUROSPITAL EU-TTG IGA UMANA	Apr 24, 2001	Substantially Equivalent	Scimedx Corp.
K002107	IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.	Aug 04, 2000	Substantially Equivalent	Scimedx Corp.
K994379	EU-TTG IGA ELISA	Feb 18, 2000	Substantially Equivalent	Scimedx Corp.
K993612	BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA	Dec 21, 1999	Substantially Equivalent	The Binding Site, Ltd.
K993034	MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD	Nov 01, 1999	Substantially Equivalent	Medica, Inc.
K992878	ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST	Oct 15, 1999	Substantially Equivalent	Immco Diagnostics, Inc.
K984137	QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA	Jan 28, 1999	Substantially Equivalent	Inova Diagnostics, Inc.
K981209	MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS	Oct 22, 1998	Substantially Equivalent	The Binding Site, Ltd.
K982366	QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA	Aug 27, 1998	Substantially Equivalent	Inova Diagnostics, Inc.