Sysmex America, Inc. (Mundelein, IL, USA), a medical diagnostic instrument manufacturer and information systems developer, announced that its Sysmex XT-4000i automated hematology analyzer has been cleared by the U.S. Food and Drug Administration (FDA). The Sysmex XT-4000i provides 34 parameters, including the advanced clinical parameters, IG 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 rapid, reliable results essential in patient diagnosis and therapeutic monitoring.

"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,” said John Kershaw, president and CEO, Sysmex America.

The system's RET-He parameter, which quantifies the hemoglobin content of reticulocytes, is an established parameter in the U.S. 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 iron replacement in these patients.

Sysmex America, the U.S. headquarters of Sysmex Corp. (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation, and information systems. Sysmex focuses on extending the boundaries of diagnostic science while providing the management information tools that make a real difference in clinical and operational results for people worldwide.

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