# P110029: Architect Hbsag Qualitative, Qualitative Confirmatory, Confirmatory Manual Diluent, Calibrators, and Controls

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Apr 12, 2012 after 261 days
- Product code: LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen))
- Device class: 2
- Regulation: 21 CFR 866.3172
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Dec 18, 2012 · Class II · Z-0987-2013: Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available 

Source page: https://510kreport.com/device/P110029
Methodology: https://510kreport.com/methodology