For Professionals in Research and Clinical Diagnostics
Overview
The software that controls the BD FACSLyric™ Flow Cytometry System comprises two applications, BD FACSuite™ Clinical Application and BD FACSuite™ Application. Both applications provide an easy-to-use interface for data acquisition and analysis with the BD FACSLyric™ System.
The BD FACSuite™ Clinical Application supports BD IVD assays with predefined assay templates.
The BD FACSuite™ Application is designed for user-defined assays and collaboration through the unique assay transfer feature, providing simple, reproducible and transferrable assay setup facilitating instrument-to-instrument and site-to-site standardization.
Functions included in both applications, including password protection, audit trail, electronic signatures and IQ/OQ procedures, assist in supporting 21 CFR Part 11 compliance and electronic record integrity.
APPLICATION
The BD FACSuite™ Application provides a streamlined workflow and automated standardization enabling collaboration
A streamlined workflow
BD® CS&T Beads are used to perform comprehensive checks during system initialization and setup, including performance QC; verify system performance; ensure that detector settings are optimal; and trigger the automated laser alignment process if required. This functionality enabled by the BD FACSuite™ Application ensures the entire setup process can be performed without manual intervention.
Spillover value measurement is performed every 60 days using predispensed dried BD® FC Beads. Spillover values are maintained within the software and updated automatically with PMTV changes.
Standardization and collaboration
Universal setup is an automated system that establishes and maintains instrument MFI target values on a single instrument using the BD FACSuite™ Application, BD® CS&T Beads and BD® FC Beads, allowing for reproducible and consistent results within and between BD FACSLyric™ instruments over time.
BD FACSLyric™ Flow Cytometers are Class 1 Laser Products. The BD FACSLyric™ Flow Cytometer is for In Vitro Diagnostic Use with BD FACSuite™ Clinical Application for up to six colors. The BD FACSLyric™ Flow Cytometer is for Research Use Only with BD FACSuite™ Application for up to 12 colors. Not for use in diagnostic or therapeutic procedures.
Cy is a trademark of Global Life Sciences Solutions Germany GmbH or an affiliate doing business as Cytiva.
Refer to manufacturer's instructions for use and related User Manuals and Technical data sheets before using this products as described.
Comparisons, where applicable, are made against older BD Technology, manual methods or are general performance claims. Comparisons are not made against non-BD technologies, unless otherwise noted.
