# P850048: Tandem-R Psa Immunoradiometric Assay

- Pathway: PMA
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 25, 1986 after 231 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K984289: Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa Reagent Pack (1999), 0 descendants of its own
- K974816: Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229 (1998), 0 descendants of its own
- K965085: Enzymun-Test Psa (1997), 0 descendants of its own

Source page: https://510kreport.com/device/P850048
Methodology: https://510kreport.com/methodology