# P060007: Architect Hbsag Reagent Kit, Calibrators,  Controls, Confirmatory Reagent Kit, Confirmatory Manual Diluent

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Sep 7, 2006 after 195 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
- Apr 24, 2025 · Class II · Z-1847-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the

Source page: https://510kreport.com/device/P060007
Methodology: https://510kreport.com/methodology