BD Announces FDA 510(k) Clearance of BD Vacutainer(R) Rapid Serum Blood Collection Tube
FRANKLIN LAKES, N.J., Oct. 6 /PRNewswire/ — BD Diagnostics – Preanalytical Systems, a unit of BD (Becton, Dickinson and Company), announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD VacutainerÃ‚® Rapid Serum Tube, a blood collection device designed to help acute healthcare facilities rapidly analyze blood serum for patient diagnosis.
“Blood test results drive many important medical decisions, including how to treat or medicate patients,” said Ana Stankovic, MD, Vice President, Medical and Scientific Affairs and Clinical Operations for BD Diagnostics – Preanalytical Systems. “Technologies such as the BD Vacutainer Rapid Serum Tube can help reduce the time it takes to get answers from blood tests and have a significant impact on patient care and hospital productivity.”
The new BD Vacutainer Rapid Serum Tube is the first serum blood collection tube with a gel additive to be launched in the United States that can be centrifuged only five minutes after the tube is filled. Standard serum tubes require a 30-minute clot time prior to centrifugation. This reduction in clot time significantly shortens sample processing time and the time it takes for clinical laboratory professionals to begin analyzing and getting test results.
“By taking essentially one sixth of the time of standard serum tubes to clot, the BD Vacutainer Rapid Serum Tube is poised to help facilities significantly improve patient throughput, especially in places like emergency rooms where decisions to admit or treat patients are often based on blood test results,” said Stankovic.
About BD Vacutainer Blood Collection Products
The widely accepted standard of collecting blood (phlebotomy) for medical diagnostic analysis is performed with a phlebotomy needle and evacuated tube. The vacuum force inside the tube gently draws blood from the patient’s vein through the phlebotomy needle and into the evacuated tube. BD offered the first such device for sale in 1949, the Evacutainer, which was invented by Joseph Kleiner. Producing more than 4 billion units annually for use in human healthcare, veterinary care and medical research, BD remains the world’s largest manufacturer of evacuated blood collection tubes.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people’s health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit http://www.bd.com.
SOURCE BD-Becton Dickinson