# P080023: Architect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Apr 10, 2009 after 225 days
- Product code: SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays)
- Device class: 2
- Regulation: 21 CFR 866.3173
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K260046: Elecsys Anti-HBc II (2026), 0 descendants of its own
- K253687: Access anti-HBc Total (2026), 0 descendants of its own

Source page: https://510kreport.com/device/P080023
Methodology: https://510kreport.com/methodology