FDA Grants Diazyme 510(k) Clearance to Market Its D-Dimer Assay for Clinical Chemistry Analyzers

Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its D-Dimer assay. In line with current clinical needs, Diazyme's D-Dimer latex-enhanced immunoturbidimetric assay can be utilized to measure total levels of D-Dimer in plasma samples as part of a work up of patients with blood clotting issues.

Utilization of this technology allows for highly reliable and precise test results, with minimal sample volumes. The D-Dimer assay is both fast and flexible with complete test results in minutes. Furthermore, the assay has been designed to work on most high throughput clinical chemistry analyzers, allowing users faster results and improved laboratory workflow.

Diazyme's D-Dimer assay is an important new tool to aid in detecting the presence of intravascular coagulation and fibrinolysis. By quantitatively determining the concentration of the clotting proteins such as fibrinogen and fibrin degradation products (D-Dimer) in human plasma, Diazyme's new assay can assist in the evaluation of patients with abnormal clotting.

"Diazyme's D-Dimer assay provides a precise, flexible and cost effective test method for laboratories of virtually all sizes," said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. "The sensitivity of the assay allows D-Dimer levels to be measured very efficiently and effectively."