# DEN260027: Elecsys HBsAg II quant II RxDx

- Pathway: De Novo (Direct)
- Applicant: Roche Diagnostics
- Decided: Oct 20, 2026 after 140 days
- Product code: SJM
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

Source page: https://510kreport.com/device/DEN260027
Methodology: https://510kreport.com/methodology