# K965085: Enzymun-Test Psa

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 19, 1997 after 90 days
- Product code: LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P850048 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P850048: Tandem-R Psa Immunoradiometric Assay, Beckman Coulter, Inc. (1986) Summary page 1.

## Indications for use
Enzyme-linked immunosorbent assay for the quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma.

Source page: https://510kreport.com/device/K965085
Methodology: https://510kreport.com/methodology