# K210901: Elecsys Vitamin D total III

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 1, 2021 after 159 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: 9 generations back to K931172 (1993). 27 ancestors in all.
1 later device descends 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)
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5, Roche Diagnostics (2017) Summary page 4.

## Most influential descendants
- K221817: ALFIS Vitamin D, ALFIS-3 Analyzer (2023), 0 descendants of its own

## Indications for use
Binding assay for the in vitro 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 cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K210901
Methodology: https://510kreport.com/methodology