FDA Clears Sysmex XE-2100D Hematology Analyzer For Blood Processing Center Quality Control Release Testing

Main Category: Blood / Hematology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 23 Sep 2009 - 2:00 PDT

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Sysmex, a global leader in medical diagnostic testing equipment and information systems technology, announced that its Sysmex XE-2100D Automated Hematology Analyzer has been cleared by the United States Food and Drug Administration (FDA) for blood processing center Quality Control release testing of post-processed red blood cell and platelet components collected using a variety of anticoagulants. Historically, the Sysmex XE-2100D had been cleared for in vitro diagnostic use in clinical laboratories and donor centers as a multi-parameter hematology analyzer for whole blood samples using EDTA anticoagulant. Sysmex is the only original equipment manufacturer to receive FDA cleared anticoagulant Intended Use claims for the Blood Center/Blood Bank market that addresses Quality Control needs, said John Kershaw, CEO, Sysmex America, Inc.

"The nation's blood centers play a critical role in servicing the blood transfusion needs of hospitals across the country. As a best-in-class hematology instrument provider, Sysmex continued development based on blood center customer input. We invested the time and money necessary to conduct the extensive studies required by the FDA to achieve this clearance milestone. The ability to use the XE-2100D with these anticoagulants enables blood centers to meet the FDA's rigorous manufacturing classification demands. It streamlines the validation and documentation process necessary to meet those requirements, providing the potential for improving efficiency and labor utilization," said Kershaw.

Since blood centers are classified as manufacturing organizations, they are highly regulated by the FDA. All instruments and products are to be used according to the manufacturer's intended use and instructions. Any deviation from any of the manufacturers' intended use statements requires extensive validation and documentation by the blood centers. The Intended Use clearance for the Sysmex XE-2100D greatly reduces the validation effort needed prior to placing the XE-2100D into production. This means a significant saving in time, materials and labor, explained Kershaw. No other currently available hematology analyzer has been cleared for such use.

About Sysmex XE-2100D Blood Center Anticoagulant Clearance

The Sysmex(R) XE-2100D Automated Hematology Analyzer is intended for in vitro diagnostic use in clinical laboratories and donor centers on EDTA anticoagulated whole blood.

Also, in blood processing centers the XE-2100D can now be used as a multi-parameter hematology analyzer and for QC release testing of the following post-processed components:

-- Red blood cell components for RBC, HGB and HCT parameters using CPD, CP2D, ACD-A, CPDA-1 as anticoagulants.

-- Platelet components for PLT and MPV parameters using CPD and ACD-A as anticoagulants.

About the Sysmex XE-2100D Automated Hematology Analyzer

The Sysmex XE-2100D Automated Hematology Analyzer utilizes Sysmex's advanced, hydro-dynamically focused, impedance technology and state-of-the-art cell-counting methods to rapidly and accurately measure parameters such as hemoglobin, hematocrit (direct) and platelet count. The analyzer has extended linearity capabilities required for concentrated cell preparations that make up component therapy, eliminating the need for dilution. Sysmex automated hematology analyzers also rank the industry's best in performance and reliability according to IMV Service Trak(TM) independent industry surveys.

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 40 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.

Source: Sysmex America

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