BD Secures FDA Clearance for New Automated Clinical Flow Cytometry Solution
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BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™ Flow Cytometer with the Integrated BD FACSDuet™ Sample Preparation System.
The new integrated system enables clinical laboratories to fully automate the sample to answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the BD FACSLyric™ Flow Cytometer.
The BD FACSDuet™ Sample Preparation System builds new capabilities into the BD portfolio of clinical flow cytometry solutions offering a pre-analytical system, that combined with the BD FACSLyric™ Flow Cytometer is the first truly walkaway sample-to-answer solution for clinical labs.
Physical integration between the BD FACSDuet™ Sample Preparation System and the BD FACSLyric™ Flow Cytometer allows technicians to load samples and reagents onto the BD FACSDuet™ Sample Preparation System and obtain results once the samples are acquired and analyzed on the BD FACSLyric™ Flow Cytometer. Data integration using the BD FACSLink™ Middleware Solution offers bidirectional communication between the instruments and connectivity with laboratory information systems (LIS).
"Flow cytometry in the clinical lab is a complex process that involves multiple workflows and manual steps. There is therefore a need for lean and effective technologies to reduce lab costs, increase quality and limit error rates. The BD FACSDuet™ Sample Preparation System is the continuation of our 45-year history of making reliable flow cytometry solutions that are robust, easy to use and improve the clinical lab workflow," said Puneet Sarin, president of Biosciences at BD.
Automation solutions for flow cytometry such as the BD FACSDuet™ and BD FACSLyric™ Complete Sample-to-Answer Solution helps to improve accuracy and standardization from instrument-to-instrument and operator-to-operator, enhancing throughput and providing consistent results that clinicians depend on to inform patient care.
The BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System is now available as an in vitro diagnostic (IVD) system in the United States as well as countries recognizing the CE-IVD certification, which was achieved in March 2019.