# K051543: Elecsys Precicontrol Bone

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 17, 2005 after 129 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 K960171 (1996). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993706: Elecsys Serum B-Crosslaps/Serum Immunoassay, Roche Diagnostics Corp. (2000) Summary page 1.

## Most influential descendants
- K111506: Elecsys Precicontrol Varia 3 (2011), 3 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own
- K182012: ADVIA Centaur Calcitonin (CALCT) assay (2018), 0 descendants of its own

## Indications for use
PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K051543
Methodology: https://510kreport.com/methodology