Waters Secures FDA 510(k) Clearance for Bloodstream Infection Diagnostics

Waters Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its BD BACTEC FXI Culture System, allowing the company to commercialise the system in the United States. 

The approval provides clinical laboratories with a fully automated blood culture platform designed to improve the speed, consistency and accuracy of diagnosing bloodstream infections and sepsis.

Clinical study findings showed that the system reduced the average time to detect infections by around three hours, representing a 15% improvement compared with the previous-generation BD BACTEC FX Blood Culture System. 

Faster detection supports earlier identification of disease-causing pathogens and enables healthcare professionals to begin targeted antimicrobial treatment sooner, an important factor in managing patients with suspected sepsis where delays in treatment can increase mortality.

The BD BACTEC FXI Culture System introduces automated gravimetric measurement of blood culture vial volume, helping laboratories confirm that the correct blood volume has been collected. 

This feature reduces variability during sample preparation and supports recommended collection practices, leading to more reliable diagnostic results.

Designed for high-throughput microbiology laboratories, the system automates vial loading, unloading, incubation and detection alerts. It can automatically load up to 60 vials at a time and is available in 480- and 960-vial configurations, helping laboratories improve workflow efficiency while reducing manual handling. 

The system has also received CE marking under the European Union's In Vitro Diagnostic Regulation and regulatory approval in Japan, expanding its availability across international markets.