# K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 24, 2012 after 236 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931172 (1993). 25 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls, Biokit, S.A. (2011) Summary page 6.
- K103221: Elecys HGH Calset, Elecsys HGH Calcheck 5, Roche Diagnostics (2010) Summary page 4.
- K102157: Elecsys Precicontrol Multimarker, Roche Diagnostics (2010) Summary page 4.
- K112528: Elecsys T4 Calcheck 5, Roche Diagnostics Corporation (2011) Summary page 14.

## Most influential descendants
- 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
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K210901: Elecsys Vitamin D total III (2021), 1 descendant of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own
- K221817: ALFIS Vitamin D, ALFIS-3 Analyzer (2023), 0 descendants of its own

## Indications for use
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxy vitamin D in human serum and plasma. The Elecsys Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Eleesys Vitanmin D CalSet is used for calibrating the quantitative Eleesys Vitamin D assay on the Eleesys and cobas e inmmnoassay analyzers. Eleesys PreciControl Varia 3 is used for quality control of specified Elecsys inmmnoassays on Elecsys and cobas e inimunoassay analyzers. The Eleosys Vitamin 0 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Eleosys and cobas e inmmoassay analyzers.

Source page: https://510kreport.com/device/K113546
Methodology: https://510kreport.com/methodology