# K974189: Elecsys Psa (on Elecsys 1010)

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 6, 1998 after 60 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 K964351 (1997). 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)
- K964351: Elecsys Psa Assay, Boehringer Mannheim Corp. (1997) Summary page 2.

## Indications for use
Immunoassay for the in vitro quantitative dctermination of Prostate-Specific Antigen (PSA) in human serum and'plasma. The Elecsys PSA assay is further indicated for serial measure of PSA to aid in the management of prostate cancer. The eclectrochemiluminescence immunoassay “ECLIA™ is intended for use on the Bochnnger Mannheim Elecsys 2010 and 1010 immunoassay analyzers.

Source page: https://510kreport.com/device/K974189
Methodology: https://510kreport.com/methodology