FDA Clears BD BACTEC FXI Culture System for Enhanced Bloodstream Infection Diagnostics
Waters Corporation has announced that the BD BACTEC FXI Culture System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows the system to be commercialized in the United States, offering laboratories a fully automated blood culture system designed to improve the speed, consistency, and accuracy of diagnosing sepsis and bloodstream infections. The BD BACTEC FXI Culture System reduces the mean time to detection by approximately three hours compared to its predecessor, enabling earlier pathogen identification and more timely targeted antimicrobial therapy. This advancement is crucial as each hour of delayed sepsis treatment can significantly increase mortality rates. The system features an automated gravimetric measurement of blood culture vial volume, reducing pre-analytical variability and supporting consistent diagnostics. 
