# K962975: Prostate Specific Antigen (Rsa) Control Moddule (Psacm)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 29, 1996 after 29 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K971051: Immulite Thyroid Autoantibody Control Module (1997), 0 descendants of its own
- K965114: Tumor Marker Control (1997), 0 descendants of its own

## Indications for use
Device intended as an aid in monitoring the performance of DPC's Coat-A-Count® PSA IRMA assay and the IMMULITE PSA assay.

Source page: https://510kreport.com/device/K962975
Methodology: https://510kreport.com/methodology