# K964595: Opus Psa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jun 24, 1997 after 218 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
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. The FDA summary names its predicate without a number.
- (no number) Hybritech Tandem-E PSA: named in the summary without a submission number

## Indications for use
OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.

Source page: https://510kreport.com/device/K964595
Methodology: https://510kreport.com/methodology