# K964351: Elecsys Psa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 25, 1997 after 266 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) Tosoh Aia-Pack PA: named in the summary without a submission number

## Most influential descendants
- K982949: Elecsys Psa, Model 2010 (1998), 0 descendants of its own
- K974189: Elecsys Psa (on Elecsys 1010) (1998), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of prostate cancer, The electrochemiluminescence immuncassay “ECLIA” is intended for use on the Boshringer Mannheim Elecsys 2010 immunoassay analyzers.

Source page: https://510kreport.com/device/K964351
Methodology: https://510kreport.com/methodology