# K981839: Acs:Centaur PSA2 Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Aug 12, 1998 after 78 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K920030: Sureseal Endoscopic Valve, Applied Urology, Inc. (1992). The summary prints P920030, a PMA number, which our reading took as K920030, FDA’s number for Sureseal Endoscopic Valve (Applied Urology, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ACS:180 PSA2 Immunoassay”. Kept off the family tree. Summary page 1.

## Indications for use
The Chiron Diagnostics ACS:Centaur PSA2 Immunoassay is for the quantitative determination of prostate specific antigen in serum to aid in the management of cancer patients in whom changing concentrations of PSA are observed using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K981839
Methodology: https://510kreport.com/methodology