# NIY: Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2002: 1
- 2012: 1
- 2013: 1

## Most-cited predicates
- K021482: Quanta Lite Sla (Soluble Liver Antigen) Elisa (2002), cited by 2

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