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Home » Becton Dickinson wins 510(k) for Vacutainer Barricor tubes

Becton Dickinson wins 510(k) for Vacutainer Barricor tubes

September 29, 2016 By Fink Densford

Becton DickinsonBecton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its Vacutainer Barricor plasma blood collection tube.

The Franklin Lakes, N.J.-based company touted improvements to the next-gen blood collection and separation device, saying its designed to improve sample quality, speed up result returns and improve patient care and clinical efficiency.

“As we launch BD Barricor tubes in the U.S., we are effectively eliminating the tradeoff of superior sample quality versus quick turnaround often faced by laboratory technicians by providing both a cleaner and faster plasma sample than current methods. This revolutionary technological advancement can improve the accuracy and speed of clinical decision making, and result in enhanced patient care,” preanalytical systems worldwide prez John Ledek said in a prepared statement.

The BD Barricor tube is a single-use, plastic, evacuated tube obtain plasma for in vitro diagnostic use, and operates with a novel mechanical separation technology to obtain plasma from whole blood samples. The company said the mechanical separator technology is designed to reduce centrifugation time from 10 minutes to 3 minutes and reduce cellular contamination by 50 to 65% compared to plasma gel tubes.

The company said the device is now commercially available in the U.S.

Last week, Becton Dickinson said it is investing $100 into expanding its Holdrege, Neb.-based facility to make extra room for insulin syringe manufacturing operations.

The investment will support new manufacturing equipment and tech to expand production for BD insulin syringes, the company said. BD currently produces more than 2 billion insulin syringes per year.

Filed Under: 510(k), Blood Management, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: becton dickinson

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