BD’s automated flow cytometry system wins FDA clearance

Becton Dickinson (NYSE:BDX) today announced it has received 510(k) clearance from the FDA for its FACSLyric flow cytometer with the integrated BD FACSDuet sample preparation system.

The system enables clinical laboratories to fully automate the sample-to-answer process and improve their efficiency by reducing errors and limiting the manual user interactions required to run assays on the BD FACSLyric flow cytometer. Physical integration between the sample prep system and the flow cytometer allows technicians to load samples and reagents and obtain results once the samples are acquired and analyzed on the flow cytometer. Data integration using BD’s FACSLink Middleware software offers bidirectional communication between the instruments and connectivity with laboratory information systems.

“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,” said BD biosciences president Puneet Sarin in a news release. “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.”

The integrated system achieved CE-IVD certification in the EU in March 2019.

Original Article: (http://feedproxy.google.com/~r/MedicalDesignAndOutsourcing/~3/2wSTT_gMkBE/)