# K980716: Advantage Chemiluminescence Prostate Specific Antigen (Psa) Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Apr 3, 1998 after 86 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

## Indications for use
Intended for use with the Nichols Advantage Specialty System for the quantitative determination of prostate specific antigen (PSA) in human serum and is to be used as an adjunct in the management of patients with prostate cancer.

Source page: https://510kreport.com/device/K980716
Methodology: https://510kreport.com/methodology