Diazyme Receives 510(K) FDA Clearance for Sodium Enzymatic Assay Kit
SAN DIEGO, CA - October 4, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Sodium Enzymatic Assay Kit for the quantitative in vitro determination of sodium in serum samples.
Sodium is determined enzymatically via sodium dependent β-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.
Key Assay Characteristics: Diazyme's Sodium Enzymatic assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 10 minutes by measuring absorbance at 405nm. No off line pretreatment is needed. The assay has excellent accuracy and precision with a wide measuring range (100 to 180 mmole/L).
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