MSV · System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | MSV |
|---|---|
| Device Name | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | Feb 6, 2026 | SESE |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | Jun 25, 2018 | SESE |
| 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 | Immco Diagnostics, Inc. | Jun 19, 2017 | SESE |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | Inova Diagnostics, Inc. | Dec 21, 2015 | SESE |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. | Inova Diagnostics, Inc. | Feb 13, 2015 | SESE |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | Phadia US, Inc. | Jun 22, 2012 | SESE |
| K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS | Instrumentation Laboratory CO | May 21, 2010 | SESE |
| K092757 | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR | Thera-Test Laboratories, Inc. | Oct 9, 2009 | SESE |
| K072032 | IGG ANTI-ATHEROX TEST KIT | Corgenix, Inc. | Apr 4, 2008 | SESE |
| K062217 | AESKULSKA BETA2-GLYCO-A | Aesku, Inc. | Dec 13, 2006 | SESE |
| K040452 | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 | Pharmacia Deutschland GmbH | May 11, 2004 | SESE |
| K040451 | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 | Pharmacia Deutschland GmbH | May 11, 2004 | SESE |
| K040450 | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 | Pharmacia Deutschland GmbH | May 11, 2004 | SESE |
| K040449 | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 | Pharmacia Deutschland GmbH | May 11, 2004 | SESE |
| K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | Immco Diagnostics, Inc. | Sep 9, 2003 | SESE |
| K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | Immco Diagnostics, Inc. | Sep 9, 2003 | SESE |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | Corgenix, Inc. | Jul 7, 2003 | SESE |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | Axis-Shield Diagnostics, Ltd. | Jun 19, 2003 | SESE |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | Hycor Biomedical , Ltd. | Mar 21, 2003 | SESE |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | Hycor Biomedical, Inc. | Dec 18, 2002 | SESE |
Top Applicants
- Corgenix, Inc. — 8 clearances
- Inova Diagnostics, Inc. — 7 clearances
- The Binding Site, Ltd. — 4 clearances
- Pharmacia Deutschland GmbH — 4 clearances
- Immco Diagnostics, Inc. — 3 clearances
