# K973099: Prostate Specific Antigen Control

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Sep 29, 1997 after 41 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.
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) aca® plus Prostate Specific Antigen Control: named in the summary without a submission number

## Indications for use
The PSA Control is an in vitro diagnostic product intended to be used as a quality control product for the Prostate Specific Antigen (PSA) method on the aca® plus immunoassay system and Dimension® clinical chemistry system with the heterogensous immunoassay module.

Source page: https://510kreport.com/device/K973099
Methodology: https://510kreport.com/methodology