Waters Receives FDA 510(k) Clearance for BD BACTEC FXI Culture System, Accelerating Bloodstream Infection Diagnostics
核心洞察
Waters Corporation (搜索) announced FDA 510(k) clearance for the BD BACTEC FXI Culture System (搜索), enabling U.S. commercialization of the next-generation automated blood culture platform.
Clinical study data demonstrated the system achieves approximately 3-hour faster time to detection (~15% reduction) compared to the previous-generation system, potentially improving sepsis (搜索) patient outcomes.
The system features industry-leading automation with 50% increased vial loading capacity and first-of-its-kind automated gravimetric blood volume measurement to improve diagnostic consistency.
Waters Corporation (搜索) announced that the BD BACTEC FXI Culture System (搜索) has received U.S. Food and Drug Administration (FDA) 510(k) clearance, enabling commercialization in the United States. This fully automated blood culture system represents a significant advancement in bloodstream infection (搜索) diagnostics, delivering faster detection times and enhanced automation capabilities for modern microbiology laboratories.
Enhanced Detection Speed Addresses Critical Clinical Need
Clinical study data demonstrated that the BD BACTEC FXI Culture System (搜索) reduced mean time to detection by approximately three hours (~15%) compared with the previous-generation BD BACTEC FX Blood Culture System (17 hours vs. 20 hours). This improvement in diagnostic speed is particularly critical given that each hour of delayed sepsis (搜索) treatment increases mortality by 3.6% to 9.9%, making faster diagnostic workflows essential in acute care settings.
"Recent evidence-based laboratory guidelines document the beneficial clinical impact of rapid laboratory results for the detection of bloodstream infections; therefore, advancing the science of automated blood culture instruments is critical to further speed results," said Donna M. Wolk, MHA, Ph.D., D(ABMM), Division Chief, Molecular and Microbial Diagnostics and Development, Geisinger Medical Laboratories (搜索). "Reducing the time to detection for positive results is key to improving the availability of Gram stain and other tests, on which treatment decisions are based. The faster, the better."
First-of-Its-Kind Blood Volume Measurement Technology
The BD BACTEC FXI Culture System (搜索) introduces a novel automated gravimetric measurement of individual blood culture vial volume, representing the first-of-its-kind capability in a blood culture platform. This innovation addresses a significant pre-analytical challenge, as studies indicate up to 85% of blood culture vials are inappropriately filled in routine clinical practice, negatively impacting diagnostic accuracy. By objectively confirming blood volume in each vial, the system reduces pre-analytical variability and supports more consistent diagnostics and adherence to recommended collection practices.
Industry-Leading Automation and Scalability
Designed for high-throughput microbiology laboratories, the BD BACTEC FXI Culture System (搜索) features fully automated vial loading, unloading, incubation, and detection alerts. The system delivers an industry-leading automated loading capacity of up to 60 vials at a time, representing a 50% increase in vial loading compared to leading competitors. Available in 480- and 960-vial configurations, the system provides scalable efficiency while reducing manual intervention and maximizing staff walk-away time.
"Waters is proud to bring the BD BACTEC FXI Culture System (搜索) to the U.S. market, delivering an important advancement in bloodstream infection (搜索) diagnostics," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation (搜索). "This innovation reflects the scientific expertise and commitment of the Waters team to improve patient care. The system helps laboratories support earlier clinical decisions for patients with suspected sepsis (搜索) and bloodstream infections when every hour matters."
Global Regulatory Approvals and Market Expansion
The FDA 510(k) clearance follows previous regulatory approvals, including CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR) and licensing by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). The system is currently available in Europe and Japan, with Waters pursuing additional regulatory clearances in other key global markets.
In preparation for increased adoption, Waters has reinforced its manufacturing supply chain by diversifying sourcing, strengthening supplier partnerships, and improving operational resilience while maintaining quality standards to ensure consistent, reliable delivery.
The BD BACTEC FXI Culture System (搜索) and BD BACTEC Blood Culture Vials are manufactured by Becton, Dickinson and Company or its affiliates, with BD maintaining full regulatory responsibility during the transition period following Waters' acquisition of BD's Biosciences and Diagnostic Solutions businesses.