BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System

BD (Becton, Dickinson and Company), a leading global medical technology company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyric™ flow cytometer system, an easy-to-use in vitro diagnostic (IVD) system, for use with BD Multitest™ assays for immunological assessment of individuals and patients having or suspected of having immune deficiency. 

The BD FACSLyric system strengthens BD’s portfolio of clinical flow cytometry solutions available in the US. The system was CE marked to the EU IVD Directive last year.

The new flow cytometer system combines a benchtop-sized instrument with software, reagents and services to provide clinicians and scientists with accurate, reliable and repeatable results.

“The FDA clearance of the BD FACSLyric system continues BD’s drive to increase access to new innovations in clinical flow cytometry technology to more labs around the world,” said John Ledek, president of Biosciences for BD. “BD recognizes that products for the clinical market require ease of use and standardization from instrument to instrument to ensure consistent results that ultimately inform patient care.” 

BD FACSLyric supports the BD Multitest™ 4-Color assays and the BD Multitest™ 6-Color TBNK assay, which are some of the most used flow-based IVD assays. These tests determine the percentages and absolute counts of T, B and natural killer (NK) cells, as well as the CD4 and CD8 subsets of T cells. Together, these metrics can be used in the immunological assessment of individuals and patients having, or suspected of having, immune deficiency. The BD FACSLyric cell analyzer is available in four configurations to provide laboratories with the flexibility to adapt to changing clinical needs. More IVD assays will be added to the BD FACSLyric solution as they become available. 

The BD FACSLyric system is available as an IVD instrument in the US, Europe and other geographies.