# K965114: Tumor Marker Control

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Feb 20, 1997 after 62 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
Longest line of descent: 1 generation back to K962975 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962975: Prostate Specific Antigen (Rsa) Control Moddule (Psacm), Diagnostic Products Corp. (1996) Summary page 1.

## Indications for use
Device intended as an aid in monitoring the performance of DPC's tumor marker assays.

Source page: https://510kreport.com/device/K965114
Methodology: https://510kreport.com/methodology