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

6 Mar 2013

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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."

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HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Human PlasmaHuman plasma is the liquid component of blood, which carries blood components - nutrients, hormones, proteins, and waste - throughout the body. Plasma-based studies provide insights into biomarkers, immune responses, and disease mechanisms. Compare plasma handling tools and systems in our peer-reviewed product directory.Blood AnalysisThe analysis of blood is vital for many areas of life sciences and forensic investigations. Blood samples can be tested for a number of different reasons such as diagnosis, glucose levels, cholesterol and drug testing.

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