# SEI: Qualitative And Quantitative Hepatitis B Virus Antibody Assays

- Device class: 2; regulation: 21 CFR 866.3173; FDA's rule: 510(k) required
- FDA decisions: 34
- Recalls: 0 (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: 2
- 2007: 3
- 2009: 1
- 2011: 5
- 2012: 2
- 2020: 4
- 2021: 3
- 2022: 1
- 2026: 4

## Most-cited predicates
- P060035: Architect Core-M Reagent Kit/Calibrators/Controls (2007), cited by 2
- P080023: Architect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls (2009), cited by 2

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