# K172992: Diazyme EZ Vitamin D Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Jan 11, 2018 after 106 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Diazyme EZ Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) in human serum and plasma on automated chemistry analyzers. Measurement of 25-hydroxyvitamin D (25-OH-D) is for the assessment of vitamin D sufficiency. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K172992
Methodology: https://510kreport.com/methodology