October 7, 2020 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) 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, BD says.
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 make a 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).
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 U.S. as well as countries recognizing the CE-IVD certification, which was achieved in March 2019.