# K984289: Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Mar 12, 1999 after 101 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 Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

Source page: https://510kreport.com/device/K984289
Methodology: https://510kreport.com/methodology