# K973244: Active Psa Irma (DSL-9700)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Aug 3, 1998 after 339 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) DPC IMMULITE PSA assay: named in the summary without a submission number

## Indications for use
The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K973244
Methodology: https://510kreport.com/methodology