Waters Corporation has received US FDA 510(k) clearance for the BD BACTEC FXI Culture System, enabling commercialisation of the automated blood culture platform in the United States.

The clearance addresses a critical diagnostic need in bloodstream infections and sepsis, where earlier detection can support faster clinical decision-making and targeted antimicrobial therapy. Delays in sepsis treatment are associated with higher mortality risk, making laboratory turnaround time an important operational and clinical priority.

The BD BACTEC FXI Culture System is designed for high-throughput microbiology laboratories and automates vial loading, unloading, incubation and detection alerts. Clinical study data showed that the system reduced mean time to detection by approximately three hours, or around 15 percent, compared with the previous-generation BD BACTEC FX Blood Culture System.