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

BD FACSLyric Flow Cytometer System with BD Multitest Assays Offers Reliability and Consistency

Jul 19, 2017

FRANKLIN LAKES, N.J., July 19, 2017 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today 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 U.S. 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 U.S., Europe and other geographies. For more information, visit bdbiosciences.com.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

For more information on BD, please visit bd.com.

Gwen Gordon

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Monique N. Dolecki

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