Product Code: MSV FDA class 2 21 CFR 866.5660

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Immunology

A Beta-2-Glycoprotein I (B2-GPI) Antibody Test System is an in vitro diagnostic device that detects and measures antibodies against beta-2-glycoprotein I in serum, an important marker for antiphospholipid syndrome, a condition associated with thrombosis and recurrent pregnancy loss. It is FDA Class 2, requiring 510(k) clearance, with product code MSV under 21 CFR 866.5660 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: MSV
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 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243979	Aptiva APS IgA Reagent	Feb 06, 2026	Substantially Equivalent	Inova Diagnostics, Inc.
K181329	EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay	Jun 25, 2018	Substantially Equivalent	Phadia AB
K162788	ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA	Jun 19, 2017	Substantially Equivalent	Immco Diagnostics, Inc.
K152875	QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls	Dec 21, 2015	Substantially Equivalent	Inova Diagnostics, Inc.
K141274	QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.	Feb 13, 2015	Substantially Equivalent	Inova Diagnostics, Inc.
K112414	ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY	Jun 22, 2012	Substantially Equivalent	Phadia US, Inc.
K091556	HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS	May 21, 2010	Substantially Equivalent	Instrumentation Laboratory CO
K092757	THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR	Oct 09, 2009	Substantially Equivalent	Thera-Test Laboratories, Inc.
K072032	IGG ANTI-ATHEROX TEST KIT	Apr 04, 2008	Substantially Equivalent	Corgenix, Inc.
K062217	AESKULSKA BETA2-GLYCO-A	Dec 13, 2006	Substantially Equivalent	Aesku, Inc.
K040452	VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096	May 11, 2004	Substantially Equivalent	Pharmacia Deutschland GmbH
K040451	VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896	May 11, 2004	Substantially Equivalent	Pharmacia Deutschland GmbH
K040450	VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996	May 11, 2004	Substantially Equivalent	Pharmacia Deutschland GmbH
K040449	VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796	May 11, 2004	Substantially Equivalent	Pharmacia Deutschland GmbH
K030702	IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA	Sep 09, 2003	Substantially Equivalent	Immco Diagnostics, Inc.
K030701	IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA	Sep 09, 2003	Substantially Equivalent	Immco Diagnostics, Inc.
K031208	REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001	Jul 07, 2003	Substantially Equivalent	Corgenix, Inc.
K031177	DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M	Jun 19, 2003	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K030397	AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA	Mar 21, 2003	Substantially Equivalent	Hycor Biomedical , Ltd.
K022945	AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA	Dec 18, 2002	Substantially Equivalent	Hycor Biomedical, Inc.
K022944	AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA	Dec 18, 2002	Substantially Equivalent	Hycor Biomedical, Inc.
K021611	QAB2A IGG ELISA KIT HRP	Jul 12, 2002	Substantially Equivalent	Cheshire Diagnostics , Ltd.
K021610	QAB2A IGM ELISA KIT HRP	Jul 12, 2002	Substantially Equivalent	Cheshire Diagnostics , Ltd.
K020695	QAB2A IGG ELISA KIT	Apr 19, 2002	Substantially Equivalent	Cheshire Diagnostics , Ltd.
K013956	DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN	Jan 08, 2002	Substantially Equivalent	Diamedix Corp.
K013628	DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM	Dec 21, 2001	Substantially Equivalent	Diamedix Corp.
K013080	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT	Sep 28, 2001	Substantially Equivalent	Corgenix, Inc.
K013079	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT	Sep 28, 2001	Substantially Equivalent	Corgenix, Inc.
K013077	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT	Sep 28, 2001	Substantially Equivalent	Corgenix, Inc.
K991804	BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.	May 05, 2000	Substantially Equivalent	The Binding Site, Ltd.
K991803	BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.	May 05, 2000	Substantially Equivalent	The Binding Site, Ltd.
K991802	BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT	May 05, 2000	Substantially Equivalent	The Binding Site, Ltd.
K991801	BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT	May 05, 2000	Substantially Equivalent	The Binding Site, Ltd.
K992243	VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT	Aug 30, 1999	Substantially Equivalent	Hemagen Diagnostics, Inc.
K992241	VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT	Aug 30, 1999	Substantially Equivalent	Hemagen Diagnostics, Inc.
K992224	VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT	Aug 30, 1999	Substantially Equivalent	Hemagen Diagnostics, Inc.
K982434	REAADS IGA ANTI-B2GP 1 TEST KIT	Dec 22, 1998	Substantially Equivalent	Corgenix, Inc.
K982433	REAADS IGM ANTI-B2GP1 TEST KIT	Dec 07, 1998	Substantially Equivalent	Corgenix, Inc.
K982391	REAADS IGG ANTI-B2GPI TEST KIT	Dec 07, 1998	Substantially Equivalent	Corgenix, Inc.
K982879	SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY	Oct 15, 1998	Substantially Equivalent	Shield Diagnostics, Ltd.
K980230	QUANTA LITE B2 GPI SCREEN	Mar 24, 1998	Substantially Equivalent	Inova Diagnostics, Inc.
K973882	EL-B2GP1SCR	Dec 05, 1997	Substantially Equivalent	Theratest Laboratories, Inc.
K972790	THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR	Dec 05, 1997	Substantially Equivalent	Theratest Laboratories, Inc.
K973014	QUANTA LITE B2GPI IGM	Oct 20, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K973006	QUANTA LITE B2 GPI IGA	Oct 20, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K970551	QUANTA LITE B2GPI IGG	Jun 24, 1997	Substantially Equivalent	Inova Diagnostics, Inc.