# P910065: Aia-Pack Psa

- Pathway: PMA
- Applicant: Tosoh Bioscience, Inc.
- Decided: Jul 7, 1993 after 602 days
- Product code: MTF (Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer)
- Device class: 3
- 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.
2 later devices descend from it; 1 cites 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
- K124056: Frend Psa Plus (Reagent Cartridge) (2013), 1 descendant of its own
- K162378: FREND PSA PLUS (reagent cartridge) (2017), 0 descendants of its own

## Recalls of this device
- Mar 5, 2018 · Class II · Z-2067-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Source page: https://510kreport.com/device/P910065
Methodology: https://510kreport.com/methodology