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FDA Clears Sysmex XT-4000i Automated Hematology Analyzer

Sysmex America, a medical diagnostic instrument manufacturer and information systems developer, has received FDA clearance for Sysmex XT-4000i Automated Hematology Analyzer.

The Sysmex XT-4000i provides 34 parameters, including the advanced clinical parameters, IG (Immature Granulocyte) and RET-He (Reticulocyte Hemoglobin Equivalent) and a Body Fluid specific mode. It utilizes Sysmex’s patented fluorescent flow cytometry and advanced cell counting methods to deliver results essential in patient diagnosis and therapeutic monitoring.

Sysmex America said that the new automated hematology analyzer’s IG parameter provides reliable detection and quantification of circulating immature granulocytes that may be used by physicians as an early indicator of acute infection, inflammatory response or myeloproliferative disorder.

The system’s RET-He parameter, which quantifies the hemoglobin content of reticulocytes, is a parameter in the National Kidney Foundation’s KDOQI (Kidney Disease Outcomes Quality Initiative) guidelines for assessing the initial iron status of patients with chronic kidney disease on hemodialysis as well as Intravenous (IV) iron replacement in the patients.

John Kershaw, president and CEO of Sysmex America, said: “With FDA’s clearance of the Sysmex XT-4000i, we are truly in a unique position to offer a portfolio of hematology products that support the needs of small clinics to high-volume clinical laboratories in every sized hospital or Integrated Delivery Network in the nation. Additionally, the Sysmex XT-4000i offers the reliability and standardization of Sysmex’s patented flow cytometry technology platform, thereby enhancing efficiency and improving productivity without sacrificing quality or accuracy.”