# K122420: Diazyme 25-Hydroxy Vitamin D Eia Kit Diazyme 25-Hydroxy Vitamin D Eia Control Set Dia

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Nov 28, 2012 after 111 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 2.

## Indications for use
The Diazyme 25-OH Vitamin D EJA Kit is designed for the quantification of total 25-OH Vitamin D in human serum and plasma. The assay results are to be used in parallel with other clinical data to' assess the Vitamin D status of a patient. For in vitro diagnostic use only. The 25-OH Vitamin D lILA Control Kit is intended for use as quality controls for the Diazyme 25-OH Vitamin D EIlA Kit only. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K122420
Methodology: https://510kreport.com/methodology