jueves, 20 de octubre de 2016

CDRH Industry: FDA Clears Blood Collection Tube That May Yield Faster Results

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The FDA has cleared the BD Vacutainer® Barricor™ Lithium Heparin Plasma Blood Collection Tubes (BD Barricor™ Tubes), a  single-use device used to collect, separate, process, transport, and store human blood samples, for use in blood analysis and therapeutic drug monitoring. The BD Barricor tubes’ separator technology may reduce the amount of blood drawn from each patient for testing and help reduce processing time in clinical labs.
The Barricor™ Tubes contain a mechanical separator instead of the typical gel to create a barrier between the plasma and cellular components of blood samples during testing. This allows the plasma portion to be removed for other clinical lab testing, reducing the number of tubes drawn from each patient. In addition, the separator eliminates the gel that sometimes clogs instrument probes and causes lab instrument downtime. This improvement in the tools available to health care providers may lead to patients obtaining faster results.
The BD Barricor™ Tubes are not recommended for the collection of samples for blood banking or immunohematology test procedures. The BD Barricor™ Tubes are not designed for use with open blood collection systems because there is a risk of exposure to blood borne pathogens.
Please see the link below for more information on this product, its indications for use, and the basis for FDA's clearance.
BD Vacutainer® Barricor™ Lithium Heparin Plasma Blood Collection Tubes Decision Summary