Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MVM — Predicate Candidate Screening

40 FDA 510(k) clearances under this product code; the 50 most recent screened below.

125 daysmedian FDA review time

292 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days
K200230	Aptiva Celiac Disease IgG Reagent	Inova Diagnostics, Inc.	2021-08-26	574
K193604	Aptiva Celiac Disease IgA Reagent	Inova Diagnostics, Inc.	2021-06-16	541
K181871	EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay	Phadia AB	2019-03-01	232
K183313	EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMU	Euroimmun Us, Inc.	2019-02-28	91
K140691	IG_PLEX CELIAC DGP PANEL	Sqi Diagnostics Systems, Inc.	2014-11-06	232
K123713	IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY E	Immco Diagnostics, Inc.	2013-10-25	325
K130053	BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYS	Bio-Rad Laboratories, Inc.	2013-09-19	247
K102490	IGX PLEX CELIAC QUALITATIVE ASSAY	Sqi Diagnostics Systems	2011-06-02	275
K101644	QUANTA FLASH H-TTG IGG	Inova Diagnostics, Inc.	2011-03-23	286
K102964	EU-TTG IGA AND EU-TTG IGG	Grifols USA, Inc.	2011-03-07	153
K094060	QUANTA FLASH H-TTG IGA	Inova Diagnostics, Inc.	2010-10-13	286
K091520	IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA	Immco Diagnostics, Inc.	2010-03-10	292
K073145	QUANTA LITE H-TTG SCREEN	Inova Diagnostics, Inc.	2008-02-12	96
K072632	QUANTA PLEX CELIAC IGG PROFILE	Inova Diagnostics, Inc.	2008-02-11	146
K072967	QUANTA LITE F-ACTIN IGA ELISA	Inova Diagnostics, Inc.	2008-01-28	98
K071692	THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST	Theratest Laboratories, Inc.	2007-11-05	138
K063818	QUANTA PLEX CELIAC IGA PROFILE	Inova Diagnostics, Inc.	2007-06-20	180
K062787	ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL	Phadia US, Inc.	2006-12-29	102
K062583	ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL	Phadia US, Inc.	2006-12-26	116
K061408	EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT	Euroimmun Us, LLC	2006-10-05	136
K060157	IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA	Immco Diagnostics, Inc.	2006-05-25	125
K042644	AESKULISA TTG A AND AESKULISA TTG G	Aesku, Inc.	2005-06-01	247
K043433	AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA	Hycor Biomedical , Ltd.	2005-03-07	84
K041173	CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996	Sweden Diagnostics (Germany) GmbH	2004-08-02	89
K041174	CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148	Sweden Diagnostics (Germany) GmbH	2004-07-19	75
K040466	BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA	The Binding Site	2004-07-16	144
K040095	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBOD	Immco Diagnostics, Inc.	2004-03-05	45
K033744	AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA	Hycor Biomedical , Ltd.	2004-01-20	50
K032571	IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBOD	Immco Diagnostics, Inc.	2003-12-24	126
K011566	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA	Inova Diagnostics, Inc.	2001-07-09	49
K011570	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA	Inova Diagnostics, Inc.	2001-07-09	49
K010625	EUROSPITAL EU-TTG IGA UMANA	Scimedx Corp.	2001-04-24	53
K002107	IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING	Scimedx Corp.	2000-08-04	23
K994379	EU-TTG IGA ELISA	Scimedx Corp.	2000-02-18	53
K993612	BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA	The Binding Site, Ltd.	1999-12-21	57
K993034	MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL AN	Medica, Inc.	1999-11-01	53
K992878	ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST	Immco Diagnostics, Inc.	1999-10-15	50
K984137	QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN)	Inova Diagnostics, Inc.	1999-01-28	71
K981209	MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS	The Binding Site, Ltd.	1998-10-22	203
K982366	QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA	Inova Diagnostics, Inc.	1998-08-27	51

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda