NEW YORK (360Dx) – Diazyme Laboratories said today that the US Food and Drug Administration has granted 510(k) clearance for its fully automated two-reagent EZ Vitamin D assay for use on validated clinical chemistry analyzers.
Chong Yuan, managing director of Diazyme Laboratories, said in a statement that its system measures total 25-hydroxy vitamin D levels and enables clinical laboratories "of almost any size" to run a vitamin D test in house without the need for "expensive, specialized instrumentation."
The high-throughput, liquid-stable assay provides precise test results without sample pre-treatment or pre-dilution steps, and it is cost effective, Yuan said.