# K980376: The Complexed Psa Assay for the Bayer Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Apr 23, 1998 after 83 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) Bayer Immuno 1™ PSA Assay: named in the summary without a submission number

## Indications for use
The Bayer Immuno 1™ cPSA Assay is an in vitro diagnostic assay intended to quantitatively measure complexed prostate specific antigen (cPSA) in human serum on the Bayer Immuno 1™ System. Complexed prostate specific antigen (cPSA) values obtained should be used as an aid in the management (monitoring) of prostate cancer patients.

Source page: https://510kreport.com/device/K980376
Methodology: https://510kreport.com/methodology