# K133410: Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Mar 14, 2014 after 127 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: 3 generations back to K032844 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112725: Liaison 25 OH Vitamin D Total Assay, DiaSorin, Inc. (2012) Summary page 2.
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602, DiaSorin, Inc. (2007) Summary page 2.

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

Source page: https://510kreport.com/device/K133410
Methodology: https://510kreport.com/methodology