NEW Product Technology


FDA Grants Diazyme Clearance to Market New 25-Hydroxy Vitamin D Enzyme Immunoassay

Diazyme Laboratories, San Diego, Diazymehas received FDA 510(k) clearance for its new 25-Hydroxy Vitamin D assay. 

In line with current clinical needs, the assay measures total true 25-Hydroxy Vitamin D levels (D2 + D3 levels) in both serum and plasma samples.

It fully automates the removal of nonspecific protein binding and cross reactivity, thereby assuring results will be both precise and accurate. The assay is fast and flexible, with complete testing results in under 2 hours. 

The test is user-friendly and can be used manually or easily adapted for use on a wide range of fully automated microtiter plate readers, making it suitable for use in laboratories of all sizes and testing needs.

Traditionally, testing of Vitamin D levels has been predominantly used for the diagnosis and management of patients with Vitamin D deficiency. Recent clinical studies though have linked Vitamin D deficiency to various diseases including cancers, cardiovascular disease, diabetes, osteoporosis, multiple sclerosis, Alzheimer’s disease, and all-cause mortality, the company says, noting that this new understanding of importance of Vitamin D levels has driven an increase in the number of physician requests for total 25-Hydroxy Vitamin D tests in the United States and worldwide. 

The results are traceable to the National Institute of Standards and Technology (NIST) standard for vitamin D. 

[Source: Diazyme Laboratories]