# K994221: Bayer Psa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Apr 13, 2000 after 120 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 P850021 (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)
- P850021: Amer, ED. Labs. Ptca, Abbott Vascular, Inc. (1986) Summary page 1.

## Indications for use
The Bayer Diagnostics PSA Immunoassay is for the quantitative serial determination of prostate specific antigen in human serum and to aid in the management (monitoring) of patients with prostate cancer.

Source page: https://510kreport.com/device/K994221
Methodology: https://510kreport.com/methodology