# K123364: 25OH Vitamin D Total Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Diasource Immunoassays, S.A.
- Decided: Jul 15, 2013 after 256 days
- Product code: MRG (System, Test, Vitamin D)
- Device class: 2
- Regulation: 21 CFR 862.1825
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Recalls of this device
- Sep 11, 2018 · Class III · Z-0410-2019: The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.

## Indications for use
The DIAsource 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.

Source page: https://510kreport.com/device/K123364
Methodology: https://510kreport.com/methodology