# K974816: Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 20, 1998 after 59 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 P850048 (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)
- P850048: Tandem-R Psa Immunoradiometric Assay, Beckman Coulter, Inc. (1986) Summary page 1.

## Indications for use
The Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESs Immunoassay System. PSA measured by the ACCEss PSA Immunoassay, is used as an aid in the manhagement of patients with prostate cancer.

Source page: https://510kreport.com/device/K974816
Methodology: https://510kreport.com/methodology