De Novo · Granted
GrantedElecsys HBsAg II quant II RxDx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · SJM (no longer in FDA’s product-code list)
Granted on Oct 20, 2026 as a new device type through De Novo after a 140-day review.
- Decided
- Oct 20, 2026
- Review
- 140 days
- Product code
- SJM
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SJM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
https://510kreport.com/device/DEN260027 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN260027: Elecsys HBsAg II quant II RxDx.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN260027
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Record history
- FDA decision record loaded Nov 3, 2026
- Page last updated Nov 3, 2026