# P910007: Axsym Total Psa & Architect Total Psa

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Sep 25, 1991 after 208 days
- Product code: MTF (Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer)
- Device class: 3
- 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
- K994419: Fastpack Psa Immunoassay, Fastpack System (2000), 0 descendants of its own
- K990234: Qualisys Psa Immunoassay (1999), 0 descendants of its own

Source page: https://510kreport.com/device/P910007
Methodology: https://510kreport.com/methodology