PORTAGE, Mich.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its immunodiagnostics business has received 510(k) clearance of the Thermo Scientific ImmunoCAP Tryptase Assay for use on its Thermo Scientific Phadia Laboratory Systems line of automated laboratory instruments. ImmunoCAP Tryptase is the first commercially available assay in the U.S. for mast cell tryptase to be available on Clinical Laboratory Improvement Amendments (CLIA) Moderate Complexity fully automated laboratory instruments. ImmunoCAP Tryptase is now cleared for use with the Phadia® 100, Phadia 250, and Phadia 1000 instruments.
ImmunoCAP Tryptase measures the level of tryptase in serum/plasma. Human tryptase is present in mast cells, and serum/plasma basal levels of tryptase give an indication of number of mast cells. Elevated basal levels of tryptase are an indicator of systemic mastocytosis.
Systemic mastocytosis is a severe chronic disease with an increased number of mast cells in the skin and other tissues and organs. It is not possible to diagnose systemic mastocytosis based solely on physical examination. The clearance of ImmunoCAP Tryptase provides physicians with additional tools and clinical insight to make an accurate diagnosis.
The U.S. Food and Drug Administration reviewed data for the ImmunoCAP Tryptase assay through the de novo reclassification process, a regulatory pathway for low to moderate risk medical devices that are novel and not comparable to an already legally marketed device.
“Tryptase is one of the World Health Association criteria that is used for making a diagnosis of systemic mastocytosis, and with today’s clearance, laboratories throughout the U.S. can now offer tryptase testing to their customers on fully automated CLIA Moderate Complexity instruments,” said Jean Forcione, president of Thermo Fisher’s immunodiagnostics business.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.
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