# MSV: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 46
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 4
- 2006: 1
- 2008: 1
- 2009: 1
- 2010: 1
- 2012: 1
- 2015: 2
- 2017: 1
- 2018: 1
- 2026: 1

## Most-cited predicates
- K970551: Quanta Lite B2GPI Igg (1997), cited by 4
- K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls (2010), cited by 3
- K013079: Reaads Anti-Beta 2 Glycoprotein I Iga Test Kit (2001), cited by 1
- K973014: Quanta Lite B2GPI Igm (1997), cited by 1
- K040449: Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796 (2004), cited by 1
- K031208: Reaads Igm Anti-B2GPI Test Kit, Model 038-001 (2003), cited by 1
- K112414: Elia  B2-Glycoprotein I Iga Immunoassay (2012), cited by 1
- K040451: Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896 (2004), cited by 1
- K040450: Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996 (2004), cited by 1
- K973006: Quanta Lite B2 Gpi Iga (1997), cited by 1

Source page: https://510kreport.com/product-code/MSV
Data by year (CSV): https://510kreport.com/product-code/MSV.csv