# P950021: Advia Centaur & Advia Centaur CP Psa Immunoassay

- Pathway: PMA
- Applicant: Siemens Healthcare Diagnostics
- Decided: Dec 22, 1995 after 178 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K251630: Atellica IM Total PSA II (tPSAII) (2026), 0 descendants of its own

## Recalls of this device
- Aug 9, 2016 · Class II · Z-2742-2016: Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.

Source page: https://510kreport.com/device/P950021
Methodology: https://510kreport.com/methodology