Waters Corporation (NYSE: WAT) has announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This regulatory milestone enables the company to commercialize the system in the United States, providing laboratories with a fully automated blood culture solution designed to enhance the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics.
Faster Detection for Improved Patient Outcomes
Clinical study data indicate that the BD BACTEC FXI Culture System reduces the mean time to detection by approximately three hours, a roughly 15% improvement compared to the previous-generation BD BACTEC FX Blood Culture System (17 hours versus 20 hours). Faster detection allows for earlier pathogen identification and more timely targeted antimicrobial therapy for patients with suspected bloodstream infections and sepsis. Given that each hour of delayed sepsis treatment increases mortality by 3.6% to 9.9%, quicker diagnostic workflows are critical in acute care settings.
Expert Endorsement
Donna M. Wolk, MHA, Ph.D., D(ABMM), Division Chief of Molecular and Microbial Diagnostics and Development at Geisinger Medical Laboratories, emphasized the importance of rapid results. “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,” she said. “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.”
Innovative Features for Laboratory Efficiency
The BD BACTEC FXI Culture System introduces a first-of-its-kind capability in a blood culture platform: automated gravimetric measurement of individual blood culture vial volume. By objectively confirming the blood volume in each vial, the system reduces pre-analytical variability and supports more consistent diagnostics and adherence to recommended collection practices.
Designed for high-throughput microbiology laboratories, the system fully automates vial loading, unloading, incubation, and detection alerts. It offers an industry-leading automated loading capacity of up to 60 vials at a time, which is 50% more vials than the leading competitor. Available in 480- and 960-vial configurations, the BD BACTEC FXI Culture System delivers scalable efficiency while reducing manual intervention and increasing staff walk-away time.
Company Statement
Jianqing Bennett, Senior Vice President of Waters Advanced Diagnostics at Waters Corporation, expressed pride in the achievement. “Waters is proud to bring the BD BACTEC FXI Culture System to the U.S. market, delivering an important advancement in bloodstream infection diagnostics,” he said. “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 and bloodstream infections when every hour matters.”
The BD BACTEC FXI Culture System is now available for order in the United States, offering a powerful tool in the fight against sepsis and bloodstream infections.
