# K142351: 25-Hydroxy Vitamin Ds EIA

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Aug 25, 2015 after 368 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.
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 4.

## Indications for use
The 25-Hydroxy Vitamin DS EIA assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum or plasma. 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 an adult population.

Source page: https://510kreport.com/device/K142351
Methodology: https://510kreport.com/methodology