# K050387: Roche Diagnostics Elecsys Precicontrol Tumor

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 25, 2005 after 69 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 K972235 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972235: Precicontrol Tumor Marker 1 and 2, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (2016), 1 descendant of its own
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (2025), 0 descendants of its own

## Indications for use
PreciControl Tumor Marker is used for quality control of Eleesys immunoassays on Elecsys immunoassay systems. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.

Source page: https://510kreport.com/device/K050387
Methodology: https://510kreport.com/methodology