# P980007: Axsym Free Psa

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Feb 5, 2004 after 2,159 days
- Product code: MTG (Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions)
- 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.
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-1852-2025: 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/P980007
Methodology: https://510kreport.com/methodology