# K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 8, 2017 after 120 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 2 (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). 26 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5, Roche Diagnostics (2012) Summary page 5.

## Most influential descendants
- K210901: Elecsys Vitamin D total III (2021), 1 descendant of its own
- K221817: ALFIS Vitamin D, ALFIS-3 Analyzer (2023), 0 descendants of its own
- K170938: CalSet IGF-1 (2017), 0 descendants of its own
- K170678: Beta-CrossLaps CalCheck 5 (2017), 0 descendants of its own

## Recalls of this device
- Apr 27, 2018 · Class II · Z-2389-2018: The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementa
- Apr 27, 2018 · Class II · Z-2390-2018: The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementa

## Indications for use
Elecsys Vitamin D total II The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This 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 the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. CalCheck Vitamin D total II This CalCheck set 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 total II reagent on the cobas e 411 immunoassay analyzer.

Source page: https://510kreport.com/device/K162840
Methodology: https://510kreport.com/methodology