Navigation Links
FDA Clears Sysmex XE-2100D Hematology Analyzer for Blood Processing Center Quality Control Release Testing
Date:9/22/2009

MUNDELEIN, Ill., Sept. 22 /PRNewswire/ -- Sysmex, a global leader in medical diagnostic testing equipment and information systems technology, today 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. For more information about Sysmex, please visit www.sysmex.com/usa.


'/>"/>
SOURCE Sysmex America
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Global Gene Map Clears New Milestone
2. FDA Clears MDN-CGS(R) Intravenous Insulin Dosing Software
3. American Medical Association Clears Path for Adenoviral Conjunctivitis - Pink Eye - Detector
4. Congress Clears the Way for National CPR and AED Awareness Week
5. FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
6. ClearScript Offers Innovative Medication Therapy Management Program to Employee Health Plans
7. Alzheimers vaccine clears plaque but has little effect on learning and memory impairment
8. Genetic Information Nondiscrimination Act clears Senate
9. Dutch Authorize Manufacture of Vaccinogens New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial
10. FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
11. FDA Clears the DPL (Deep Penetrating Light) Therapy System for Over-the-Counter - Home Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... Raleigh, NC (PRWEB) , ... December 02, 2016 , ... ... the Open Enrollment Period (or Annual Election Period), is ending December 7th. Currently-enrolled Medicare ... plan (Part C) or prescription drug plan (Part D) need to make changes during ...
(Date:12/2/2016)... New York, NY (PRWEB) , ... December 02, ... ... today, featuring an inspirational interview of two ostomy patients, standing as living proof ... million people suffer from digestive diseases and issues that spike around the holidays. ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet ... in USA Today, which covers the innovative treatments, therapeutic technologies, and revolutionized nutrition ... lives. “We are prolonging life 6 years in the last 3 decades,” says ...
(Date:12/2/2016)... ... 02, 2016 , ... Universal Medical Systems, Inc. (UMS) the ... company to offer robotic imaging to veterinary medicine is sponsoring the appearance of ... the American Association of Equine Practitioners 62nd Annual Convention from December 4-6, 2016 ...
(Date:12/2/2016)... , ... December 02, 2016 , ... Yisrayl Hawkins, at ... into how this current generation fits into Bible Prophecy. Yisrayl says this generation, known ... pointing to this conclusion, showing how the details line up exactly with Bible Prophecy ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)...  PipelineRx, a leading medication management technology company ... of its SaaS-based telepharmacy platform, PowerGridRx™ , ... Midyear Clinical Meeting and Exhibition, December 5-7 in ... 300 hospital clients nationally, the Company is a ... dramatically improve pharmacy operations, enhance patient safety, and ...
(Date:12/2/2016)... 2016  Maxor National Pharmacy Services, LLC ("Maxor"), today announced ... ("PSI").  The combination of Texas -based Maxor ... PSI bring together both company,s clinical expertise and high-touch patient ... industry-leading specialty pharmacy. About Maxor ... , , ...
(Date:12/2/2016)... 2, 2016 Lianluo Smart Limited (Nasdaq: ... Company") which develops, markets and sells medical devices ... China and international markets, recently attended ... Treatment New Progress Forum, co-hosted by the Institute ... , Guangdong Provincial People,s Hospital and Cardiology ...
Breaking Medicine Technology: