# OBE: Anti-Ss-A 52 Autoantibodies

- Device class: 2; regulation: 21 CFR 866.5100; 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)
- 2007: 1
- 2015: 1
- 2026: 1

## Most-cited predicates
- K063565: Quanta Lite SS-a 52 Elisa (2007), cited by 2
- K141655: Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls (2015), cited by 2

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