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 Oct 09, 2009
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
K092757
Thera-Test Laboratories, Inc.
Immunology · 30d
Cleared Apr 04, 2008
IGG ANTI-ATHEROX TEST KIT
K072032
Corgenix, Inc.
Immunology · 255d
Cleared Dec 13, 2006
AESKULSKA BETA2-GLYCO-A
K062217
Aesku, Inc.
Immunology · 134d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
K040449
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
K040450
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
K040451
Pharmacia Deutschland GmbH
Immunology · 81d
Cleared May 11, 2004
VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096
K040452
Pharmacia Deutschland GmbH
Immunology · 81d
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 Mar 21, 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
K030397
Hycor Biomedical , Ltd.
Immunology · 43d
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 Jul 12, 2002
QAB2A IGM ELISA KIT HRP
K021610
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
QAB2A IGG ELISA KIT HRP
K021611
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Apr 19, 2002
QAB2A IGG ELISA KIT
K020695
Cheshire Diagnostics , Ltd.
Immunology · 46d

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 →