BD, Franklin Lakes, NJ, has received FDA premarket notification (510(k)) clearance for the BD FACSLyric flow cytometry system, an in vitro diagnostic (IVD) system for use with BD Multitest assays for immunological assessment of individuals who have or are suspected of having immune deficiency.

The system was CE marked to the European Union’s IVD Directive last year.

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

John Ledek, BD.

John Ledek, BD.

“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,” says John Ledek, president of biosciences at 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 BD Multitest 4-Color assays and the BD Multitest 6-Color TBNK assay, which 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 who have or are 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.

For more information, visit BD.