# K982473: Tumor Marker Control

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 12, 1998 after 27 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
EURO/DPC's TMC is an assayed, human serum-based, tri-level control containing several human source-derived analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro diagnostic use as an aid in monitoring the day-to-day performance of assays for these constituents.

Source page: https://510kreport.com/device/K982473
Methodology: https://510kreport.com/methodology