MSV · Class II · 21 CFR 866.5660

FDA Product Code MSV: System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

Leading manufacturers include Corgenix, Inc., Inova Diagnostics, Inc. and The Binding Site, Ltd..

46
Total
46
Cleared
133d
Avg days
1997
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 410d recently vs 127d historically

FDA 510(k) Cleared System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) Devices (Product Code MSV)

46 devices
1–24 of 46
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Jun 25, 2018
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329
Phadia AB
Immunology · 38d
Cleared Jun 19, 2017
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
K162788
Immco Diagnostics, Inc.
Immunology · 259d
Cleared Dec 21, 2015
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
K152875
Inova Diagnostics, Inc.
Immunology · 82d
Cleared Feb 13, 2015
QUANTA FLASH ¿2GP1-DOMAIN1
K141274
Inova Diagnostics, Inc.
Immunology · 273d
Cleared Jun 22, 2012
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414
Phadia US, Inc.
Immunology · 305d
Cleared May 21, 2010
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556
Instrumentation Laboratory CO
Immunology · 359d
Cleared Apr 04, 2008
IGG ANTI-ATHEROX TEST KIT
K072032
Corgenix, Inc.
Immunology · 255d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
K030702
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208
Corgenix, Inc.
Immunology · 81d
Cleared Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177
Axis-Shield Diagnostics, Ltd.
Immunology · 66d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945
Hycor Biomedical, Inc.
Immunology · 104d
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956
Diamedix Corp.
Immunology · 39d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628
Diamedix Corp.
Immunology · 46d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080
Corgenix, Inc.
Immunology · 14d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
K991803
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
K991804
The Binding Site, Ltd.
Immunology · 345d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224
Hemagen Diagnostics, Inc.
Immunology · 60d

About Product Code MSV - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code MSV since 1997, with 46 receiving FDA clearance (average review time: 133 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MSV Product Code

Recent submissions under MSV have taken an average of 410 days to reach a decision - up from 127 days historically. Manufacturers should account for longer review timelines in current project planning.

MSV devices are reviewed by the Immunology panel. Browse all Immunology devices →