Healthcare Industry News:  hematology analyzer 

Diagnostics FDA

 News Release - July 25, 2006

FDA Clears Body Fluids Analysis Application for Sysmex XT-Series

Mid Volume Laboratories to Benefit

MUNDELEIN, Ill., July 25 (HSMN NewsFeed) -- Sysmex America, Inc. announced today that the Body Fluid application on the Sysmex XT-2000i(TM) and Sysmex XT-1800 (TM) Automated hematology analyzers has been cleared by the United States Food and Drug Administration (FDA) for the analysis of cerebrospinal fluid (CSF), serous and synovial fluids, said John Kershaw, President, Sysmex America, Inc. The XT-series analyzer is an instrument designed for mid volume laboratories. The Body Fluid application on the Sysmex® XE-Series Automated hematology analyzer, designed for high volume testing, was cleared by the FDA in 2004.

Body Fluid analysis consists of an automated white blood count (WBC) and red blood count (RBC). The WBC count is obtained on the XE and XT-Series analyzers from the Differential Channel, which uses Sysmex's patented Fluorescent Flow Cytometry technology to separate WBC's into distinct cell clusters. The RBC count is obtained using DC detection with Hydrodynamic focusing. No specimen preparation is needed before sample analysis.

According to Dr. Ian Giles, Director of Scientific Affairs, Sysmex America, Inc., "Superior analytical sensitivity afforded by the use of fluorescent technology for leukocyte counting and differentiation is what gives Sysmex products the ability to excel in this arena. Competence at a reagent and technology level is paramount, as inadequacies cannot be fully compensated for mathematically. Providing body fluid analysis on the XT-Series analyzers indicates our continued commitment to our 'best of breed' philosophy in hematology."

"With FDA's clearance of Body Fluids on the XT-Series, Sysmex is truly in a unique position of being able to offer automated body fluid analysis on both our flagship XE series analyzers as well as our middle volume testing laboratory settings who utilize the XT-Series analyzers. Whether it is a middle volume laboratory or a larger institution, we are the only vendor that can offer the laboratorians the same powerful diagnostic capabilities, including our fluorescent flow technology, across the instrument range," said John Kershaw, President, Sysmex America, Inc.

This announcement marks Sysmex America's second FDA clearance in 2006. In March, the Sysmex XS-1000i Automated hematology analyzer was cleared for use in smaller clinical laboratories and physician offices.

About Sysmex America, Inc.

Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems. Serving customers for over 35 years, 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. For more information about Sysmex, please visit http://www.sysmex.com/usa .


Source: Sysmex America

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