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FDA Grants BD 510(k) Clearance for New Immunological Dx System

The story has been updated to correct the spelling of John Ledek's name. We regret the error. 

NEW YORK (360Dx)  –  Becton Dickinson announced today that it has received 510(k) clearance from the US Food and Drug Administration for its BD FACSLyric flow cytometer system.

The new flow cytometer system combines a benchtop-sized instrument with software, reagents, and services to provide clinicians and scientists with accurate and repeatable results, BD said. The instrument is for use with BD Multitest assays for immunological assessments of individuals and patients having or suspected of having immune deficiency.

These include the BD Multitest 4-color assays and the BD Multitest 6-Color TBNK assay. The tests determine the percentages and absolute counts of T, B, and natural killer cells, and the CD4 and CD8 subsets of T cells.

The BD FACSLyric cell analyzer is available in four configurations, and additional assays for the system will be added as they become available, BD said.

BD Biosciences President John Ledek noted that the FDA clearance will help push BD's drive to increase access to new breakthroughs in clinical flow cytometry technology in labs around the world.

"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," he added.

The company said that the FACSLyric system will strengthen its portfolio of clinical flow cytometry solutions available in the US. Clearance for its flow cytometer system with its Leucocoun assay was approved earlier this year.