# K042815: Quest Tumor Marker Control, Model 955

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 5, 2004 after 24 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: 4 generations back to K940433 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011579: Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580, Bio-Rad (2001) Summary page 1.

## Indications for use
Quest Diagnostics Tumor Marker Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K042815
Methodology: https://510kreport.com/methodology