BD Announced FDA 510(k) Clearance of BD Vacutainer® Rapid Serum Blood Collection Tube


BD Diagnostics – Preanalytical Systems, a unit of BD announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Vacutainer® Rapid Serum Tube, a blood collection device designed to help acute healthcare facilities rapidly analyze blood serum for patient diagnosis.

Ana Stankovic, MD, Vice President, Medical and Scientific Affairs and Clinical Operations for BD Diagnostics – Preanalytical Systems said, Blood test results drive many important medical decisions, including how to treat or medicate patients. 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.