# P060035: Architect Core-M Reagent Kit/Calibrators/Controls

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Nov 6, 2007 after 340 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
- K260049: Elecsys Anti-HBc IgM (2026), 0 descendants of its own
- K254059: Access anti-HBc IgM (2026), 0 descendants of its own

Source page: https://510kreport.com/device/P060035
Methodology: https://510kreport.com/methodology