# LOM: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

- Device class: 2; regulation: 21 CFR 866.3172; FDA's rule: 510(k) required
- FDA decisions: 26
- Recalls: 26 (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)
- 2017: 57
- 2018: 73
- 2019: 36
- 2020: 49
- 2021: 57
- 2022: 69
- 2023: 63
- 2024: 52
- 2025: 68
- 2026: 1

## Most-cited predicates
- P190017: LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (2020), cited by 1

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