Becton Dickinson (BD) has received the US Food and Drug Administration (FDA) 510(k) approval for its BD FACSLyric Flow Cytometer with integrated BD FACSDuet Sample Preparation System.
The medical device company claimed that its BD FACSDuet and BD FACSLyric make a complete sample-to-answer solution that helps labs improve accuracy, enhance throughput and offer reliable results.
Also, the new integrated solution would help clinical laboratories fully automate their process to reduce mistakes and manual labour to run assays on the BD FACSLyric Flow Cytometer.
BD biosciences president Puneet Sarin said: “Flow cytometry in the clinical lab is a complex process that involves multiple workflows and manual steps. There is therefore a need for lean and effective technologies to reduce lab costs, increase quality and limit error rates.
“The BD FACSDuet Sample Preparation System is the continuation of our 45-year history of making reliable flow cytometry solutions that are robust, easy to use and improve the clinical lab workflow.”
Technicians can load samples onto BD FACSDuet and get results from BD FACSLyric Flow Cytometer
The FACSDuet is a pre-analytical system that is expected to add new capabilities to the BD portfolio of clinical flow cytometry solutions.
The integration between the two instruments would facilitate the technicians load samples and reagents onto the BD FACSDuet Sample Preparation System and get results from BD FACSLyric Flow Cytometer, once it acquires the samples and completes analysing them.
BD FACSLink Middleware Solution is used for data integration for bidirectional communication between the instruments and connectivity with laboratory information systems (LIS).
The BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation System has secured the CE-IVD certification in March 2019.
The company is commercialising the integrated system as an in vitro diagnostic (IVD) system in the US, along with other countries that recognise the CE-IVD certification.
