Product Code: MST FDA class 2 21 CFR 866.5750

Antibodies, Gliadin

Immunology

An Antibodies to Gliadin test system is an immunological in vitro diagnostic device used to detect antigliadin antibodies in serum, which are markers associated with celiac disease and gluten sensitivity, aiding in diagnosis and monitoring. It is classified as FDA Class 2, requiring 510(k) clearance, with product code MST under 21 CFR 866.5750 in the Immunology specialty. The device is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

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Basic Information

Product Code: MST
Device Class: FDA class 2
Regulation Number: 866.5750
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 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K163177	ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA	Jul 28, 2017	Substantially Equivalent	Immco Diagnostics, Inc.
K132082	AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK	Dec 05, 2013	Substantially Equivalent	Aesku Diagnostics
K113377	GLIADIN IGA AND GLIADIN LGA	Dec 14, 2012	Substantially Equivalent	Grifols USA, LLC
K113863	QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS	Sep 20, 2012	Substantially Equivalent	Inova Diagnostics, Inc.
K111414	QUANTA FLASH (TM) DGP SCREEN	Oct 20, 2011	Substantially Equivalent	Inova Diagnostics, Inc.
K093459	ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01	Aug 13, 2010	Substantially Equivalent	Phadia US, Inc.
K091522	IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA	Feb 04, 2010	Substantially Equivalent	Immco Diagnostics, Inc.
K083053	EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)	Aug 07, 2009	Substantially Equivalent	Euroimmun Us, Inc.
K083052	EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)	Jul 28, 2009	Substantially Equivalent	Euroimmun Us, Inc.
K081674	BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)	Oct 15, 2008	Substantially Equivalent	The Binding Site, Ltd.
K063775	ELIA GLIADIN IGA, IGG AND CELIAC CONTROL	Mar 14, 2007	Substantially Equivalent	Phadia US, Inc.
K070083	QUANTA LITE H-TTG/DGP SCREEN	Mar 12, 2007	Substantially Equivalent	Inova Diagnostics, Inc.
K062708	QUANTA LITE CELIAC DGP SCREEN	Dec 13, 2006	Substantially Equivalent	Inova Diagnostics, Inc.
K053383	FIDIS CELIAC	Mar 29, 2006	Substantially Equivalent	Biomedical Diagnostics (Bmd) SA
K052793	IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02	Feb 07, 2006	Substantially Equivalent	Pharmacia Diagnostics AB
K052439	AESKULISA GLIA A AND AESKULISA GLIA G	Feb 07, 2006	Substantially Equivalent	Aesku Diagnostics
K052143	QUANTA LITE GLIADIN IGA II	Oct 04, 2005	Substantially Equivalent	Inova Diagnostics, Inc.
K052142	QUANTA LITE GLIADIN IGG II	Oct 04, 2005	Substantially Equivalent	Inova Diagnostics, Inc.
K041002	FIDIS CELIAC	Sep 24, 2004	Substantially Equivalent	Biomedical Diagnostics S.A.
K041357	VARELISA GLIADIN IGG ANTIBODIES	Aug 02, 2004	Substantially Equivalent	Sweden Diagnostics (Germany) GmbH
K041354	VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896	Jul 16, 2004	Substantially Equivalent	Sweden Diagnostics (Germany) GmbH
K012797	DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM	Sep 28, 2001	Substantially Equivalent	Diamedix Corp.
K012795	DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM	Sep 28, 2001	Substantially Equivalent	Diamedix Corp.
K002359	MDI GLIADIN G TEST	Oct 19, 2000	Substantially Equivalent	Micro Detect, Inc.
K002358	MDI GLIADIN A TEST	Oct 19, 2000	Substantially Equivalent	Micro Detect, Inc.
K002189	GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM	Oct 19, 2000	Substantially Equivalent	Scimedx Corp.
K002169	GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM	Oct 19, 2000	Substantially Equivalent	Scimedx Corp.
K001393	THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR	Jun 07, 2000	Substantially Equivalent	Zeus Scientific, Inc.
K993250	THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.	Nov 12, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K993087	AUTOSTAT II ANTI-GLIADIN IGG ELISA	Nov 12, 1999	Substantially Equivalent	Cogent Diagnotics , Ltd.
K993086	AUTOSTAT II ANTI-GLIADIN IGA ELISA	Nov 12, 1999	Substantially Equivalent	Cogent Diagnotics , Ltd.
K990207	GLIADIN IGA ELISA TEST SYSTEM	Mar 26, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K990204	GLIADIN IGG ELISA TEST SYSTEM	Mar 26, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K973910	GLIADIN ANTIBODIES ELISA	Feb 17, 1999	Substantially Equivalent	Genesis Diagnostics , Ltd.
K982701	UNICAP GLIADIN IGG ASSAY	Oct 22, 1998	Substantially Equivalent	Pharmacia & Upjohn Co.
K982533	UNICAP GLIADIN IGA ASSAY	Oct 22, 1998	Substantially Equivalent	Pharmacia & Upjohn Co.
K981929	BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT	Sep 03, 1998	Substantially Equivalent	The Binding Site, Ltd.
K981644	BINDAZYME ANTIGLIADIN IGG	Sep 03, 1998	Substantially Equivalent	The Binding Site, Ltd.
K964986	QUANTA LITE IGA GLIADIN ELISA	Jun 02, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K964985	QUANTA LITE IGG GLIADIN ELISA	May 30, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K964344	IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT	May 30, 1997	Substantially Equivalent	Immco Diagnostics, Inc.
K964341	IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT	May 30, 1997	Substantially Equivalent	Immco Diagnostics, Inc.