# K990234: Qualisys Psa Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Qualisys Diagnostics, Inc.
- Decided: Jul 8, 1999 after 164 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 P910007 (1991). 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)
- P910007: Axsym Total Psa & Architect Total Psa, Abbott Laboratories (1991) Summary page 1.

## Indications for use
The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.

Source page: https://510kreport.com/device/K990234
Methodology: https://510kreport.com/methodology