BD granted FDA 510 (k) clearance for flow cytometer with sample prep system

Oct. 6, 2020

BD (Becton, Dickinson and Company) has announced it 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, according to a press release.

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 company said.

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 the laboratory information systems (LIS).

BD said the flow cytometer is now available in the United States, as well as countries recognizing the CE-IVD certification, which was granted in March 2019.

Visit BD for more news