FDA product code MSV: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
MSV is the FDA product code for system,test,antibodies,b2 - glycoprotein i (b2 - gpi). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 46 510(k) submissions under MSV, 1 in the last five years, from 18 different applicants. The average 510(k) review took 133 days (median 81); 410 days on average over the last three years. FDA has posted 1 recall for MSV devices.
Classification
| Field | Value |
|---|---|
| Device name | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MSV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 259 |
| 2018 | 1 | 38 |
| 2026 | 1 | 410 |
Compare with all 510(k) review times · Search every MSV clearance
Top MSV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corgenix, Inc. | 8 | 2008-04-04 |
| Inova Diagnostics, Inc. | 7 | 2026-02-06 |
| Pharmacia Deutschland GmbH | 4 | 2004-05-11 |
| The Binding Site, Ltd. | 4 | 2000-05-05 |
| Immco Diagnostics, Inc. | 3 | 2017-06-19 |
13 more applicants have MSV clearances. See the full list in Caduvo.
Most recent MSV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243979 | Inova Diagnostics, Inc. | Aptiva APS IgA Reagent | 2026-02-06 | 410 |
| K181329 | Phadia AB | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | 2018-06-25 | 38 |
| K162788 | Immco Diagnostics, Inc. | 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 | 2017-06-19 | 259 |
| K152875 | Inova Diagnostics, Inc. | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls | 2015-12-21 | 82 |
| K141274 | Inova Diagnostics, Inc. | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. | 2015-02-13 | 273 |
Recalls for MSV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-10-26.
Frequently asked questions
What is FDA product code MSV?
MSV is the FDA product code for system,test,antibodies,b2 - glycoprotein i (b2 - gpi). It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is MSV?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSV?
Across 46 cleared submissions the average was 133 days from receipt to decision (median 81).
Which companies have the most MSV clearances?
Corgenix, Inc. (8); Inova Diagnostics, Inc. (7); Pharmacia Deutschland GmbH (4); The Binding Site, Ltd. (4); Immco Diagnostics, Inc. (3).
Have MSV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-10-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MSV
- Run a recall and safety report across every MSV manufacturer
- Watch product code MSV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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