# K123660: 25-OH  Vitamin D Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun US
- Decided: Jul 17, 2013 after 231 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: 1 generation back to K021163 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021163: Octeia 25-Hydroxy Vitamin D, Immunodiagnostic Systems, Ltd. (2002) Summary page 2.

## Most influential descendants
- K141114: Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D Calibrator Set, and Bioplex (R) 2200 25-OH Vitamin D (2015), 1 descendant of its own
- K180577: BioPlex 2200 25-OH Vitamin D Kit (2018), 0 descendants of its own

## Indications for use
EUROIMvMUN's 25-OH Vitamin D ELISA is intended for the quantitative determination of 25-OH Vitamin D and other hydroxylated vitamin D metabolites in human serum and plasma (EDTA, Li-heparin). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.

Source page: https://510kreport.com/device/K123660
Methodology: https://510kreport.com/methodology