# K972235: Precicontrol Tumor Marker 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 12, 1997 after 57 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.
3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Rad Lyphochek Immunoassay Plus Control: named in the summary without a submission number

## Most influential descendants
- K050387: Roche Diagnostics Elecsys Precicontrol Tumor (2005), 2 descendants of its own
- 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 Elecsys immunoassays using the Elecsys immunoassay systems (Elecsys 2010, 1010 and others of the Elecsys family of instruments). PreciControl Tumor Marker contains lyophilized control serum based on hurnan serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.

Source page: https://510kreport.com/device/K972235
Methodology: https://510kreport.com/methodology