# K033937: Elecsys Precicontrol Multianalyte

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 7, 2004 after 19 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: 5 generations back to K931172 (1993). 6 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032089: Roche Diagnostics Elecsys Precicontrol Cardiac, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K102157: Elecsys Precicontrol Multimarker (2010), 9 descendants of its own
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own
- K051517: Elecsys Precicontrol Anemia (2005), 8 descendants of its own
- K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys (2009), 7 descendants of its own
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), 4 descendants of its own

## Indications for use
The Elecsys® PreciControl MultiAnalyte is used for quality control of the Elecsys C-Peptide and Elecsys Insulin immunoassays on the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K033937
Methodology: https://510kreport.com/methodology