# K972021: Immulite Third Generation Psa (Lkupi,LKUP5)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 31, 1997 after 151 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 FDA summary names its predicate without a number.
- (no number) Hybritech Tandem-R® PSA: named in the summary without a submission number
- (no number) Tosoh AIA-PACK® PA: named in the summary without a submission number

## Indications for use
DPC's IMMULITE Third Generation PSA is intended for use with the IMMULITE Automated Immunoassay Analyzer. The IMMULITE Third Generation PSA is a solid-phase, chemiluminescent enzyme immunoassay designed for the quantitative measurement of prostate specific antigen (PSA) in serum. It is intended as an adjunctive test to aid in the management of prostate cancer.

Source page: https://510kreport.com/device/K972021
Methodology: https://510kreport.com/methodology