# K981455: Third Generation Psa Control Module

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: May 13, 1998 after 20 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 no predicate by number.

## Indications for use
IMMULITE Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with the IMMULITE and IMMULITE 2000 Third Generation PSA assays. It is intended as an aid in monitoring day-to-day assay performance.

Source page: https://510kreport.com/device/K981455
Methodology: https://510kreport.com/methodology