# K111506: Elecsys Precicontrol Varia 3

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 8, 2011 after 37 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931172 (1993). 25 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys, Roche Diagnostics Corp. (2009) Summary page 1.
- K051543: Elecsys Precicontrol Bone, Roche Diagnostics Corp. (2005) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- Apr 10, 2017 · Class II · Z-2173-2017: e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays

## Indications for use
Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. See the package insert for the list of all analytes claimed.

Source page: https://510kreport.com/device/K111506
Methodology: https://510kreport.com/methodology