FDA clears BD’s immunological IVD system for commercialisation
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Becton, Dickinson and Company’s (BD) in-vitro diagnostic (IVD) device, FACSLyric flow cytometer system.
The device is cleared for use with BD Multitest assays to immunologically assess patients with or suspected of having an immune deficiency.
FACSLyric is a benchtop-sized instrument that works with a combination of software, reagents and services to deliver precise, reliable and repeatable results.
BD Biosciences president John Ledek said: "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.
"BD recognises that products for the clinical market require ease of use and standardisation from instrument to instrument to ensure consistent results that ultimately inform patient care."
Flow-based IVD assays, BD Multitest 4-Colour and Multitest 6-Colour TBNK that are designed to determine percentages, and absolute counts of T, B, natural killer (NK) cells, and the CD4 and CD8 subsets of T cells will be supported by the new diagnostic system.
Available in four configurations, the BD FACSLyric flow cytometer system was CE-Marked last year to the EU IVD Directive.
With operations in more than 50 countries, BD develops medical diagnostics and technologies for medical research and clinical laboratories.
The firm works to aid research and genomics, equipment for surgical and interventional procedures, diagnosis of infectious diseases and cancer, and prevention of infections.
Image: BD FACSLyric flow cytometer system. Photo: courtesy of PRNewsfoto/Becton, Dickinson and Company.