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Becton Dickinson Gets FDA 510(k) Clearance for Fully Automated Flow Cytometry Solution

NEW YORK – Becton Dickinson announced on Monday it has been granted 510(k) clearance from the US Food and Drug Administration for its BD FACSLyric Flow Cytometer with integrated BD FACSDuet Sample Preparation System, comprising the first fully automated sample-to-answer solution for flow cytometry.

The new integrated system enables clinical laboratories to fully automate flow cytometry and improve their efficiency by reducing errors and limiting manual user interactions required to run assays on the BD FACSLyric Flow Cytometer, BD said in a statement.

Physical integration between the BD FACSDuet Sample Preparation System and the BD FACSLyric Flow Cytometer enables a walkaway sample-to-answer solution for clinical labs, allowing technicians to load samples and reagents onto the BD FACSDuet Sample Preparation System and obtain results once the samples are acquired and analyzed on the BD FACSLyric Flow Cytometer. Data integration using the BD FACSLink Middleware Solution offers bidirectional communication between the instruments and connectivity with laboratory information systems, Franklin Lakes, New Jersey-based BD said.

The BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System is now available as an in vitro diagnostic system in the US as well as in countries recognizing the CE-IVD certification, which the firm obtained last year.