BD Granted FDA 510(k) Clearance for BD FACSLyric™ Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System - Ingenious e-Brain

BD Granted FDA 510(k) Clearance for BD FACSLyric™ Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System

The leading global medical technology organization, BD (Becton, Dickinson and Company), today confirmed it had received clearance for the Integrated BD FACSDuet Sample Preparation System of 510(k) by the U.S. Food and Drug Administration (FDA). BD FACSDuet, the first fully automatic sample to response solution, improve their efficiency by reducing errors and limiting the manual user interactions when combined with the BD FACSLyric Flow cytometer.

About BD

  • By developing medical research, diagnostics, and service, BD is one of the world’s leading organizations with medical technology and is transforming healthcare.
  • Innovative equipment, programs and solutions help the clinical treatment for the patients and the operational procedures for the health care providers was built in recognition of heroes on the frontlines of healthcare.
  • The organization delivers groundbreaking strategies for medical research and genomics, diagnosing infectious diseases and cancer, developing drug delivery, promoting infection control, introducing operating processes and interventions, and facilitating diabetes care.
  • BD works with nearly all nations and collaborators globally to solve some of the world’s most daunting health problems.
  • BD will help increase quality, minimize costs, improve performance, enhance protection, and expand healthcare access through close cooperation with consumers.

Limitations Faced by the Flow Cytometer

Flow cytometry is a dynamic procedure requiring various workflows and handling measures in the clinical laboratory.
Lean and efficient technologies are needed to

  • reduce laboratory costs
  • improve efficiency and
  • minimize error rates

How FACSLyric Flow Cytometer Overcomes the Limitations?

  • The new automated framework enables the clinical laboratories to
    • automate the sample entirely
    • adapt to enhance its performance by reducing errors and
    • minimizing the manual user experiences necessary for testing the BD Cytometer FACSLyric Flow.
  • In addition to the latest features, the BD FACSDuet Sample Preparation System incorporates the clinical flow cytometry solution portfolio of BD that is the first real-time sample-to-answer solution for clinical laboratories, along with the BD FACSLyric Flow Cytometer.

“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,” said Puneet Sarin, president of Biosciences at BD.

Potential Impact

  • The physical integration of the BD FACSDuet Sample Preparation System and the FACSLyric Flow Cytometer enables technicians to load samples or reagents into the BD FACSDuet Sample Preparation System for the collection and study of samples from the BD FACSLyric Flow Cytometer and obtains result.
  • BD FACSLink Middleware Solution data integration offers bi-directional communication among instruments and lab-related (LIS) connectivity.
  • The Full Sample-to-Answer solution for automation systems for flow cytometry, such as BD FACSDuet and BD FACSLyric improves:
    • instrument-to-instrument and operator-to-operator precision and standardization
    • increases performance
    • offers reliable outcomes that patients depend on inpatient care.

Implementation

In the United States and countries that are approved as CE-IVD certificates in March 2019, BD FACSLyric Flow System with its Incorporated BD FACsDuet TM Sample Preparation System (IVD) is available as the in vitro diagnostics system.

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