Life science company Waters Corporation (NYSE: WAT) announced on Wednesday that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration 510(k) clearance, enabling commercialisation in the United States and expanding access to bloodstream infection and sepsis diagnostics.

Clinical study data showed the system reduced mean time to detection by approximately three hours, or around 15%, compared with the previous-generation BD BACTEC FX Blood Culture System, potentially enabling earlier pathogen identification and more timely antimicrobial treatment for patients with suspected sepsis.

The fully automated platform introduces automated gravimetric measurement of blood culture vial volume, designed to reduce pre-analytical variability and improve adherence to recommended blood collection practices. The system also automates vial loading, unloading, incubation and detection alerts.

Targeted at high-throughput microbiology laboratories, the BD BACTEC FXI Culture System offers automated loading of up to 60 vials at a time and is available in configurations supporting up to 960 vials per module, increasing laboratory efficiency and reducing manual intervention.

The system has also received CE marking under the European Union's In Vitro Diagnostic Regulation and has been licensed by Japan's Pharmaceuticals and Medical Devices Agency, supporting commercial availability in Europe and Japan. The BD BACTEC FXI Culture System and related blood culture vials are manufactured by Becton, Dickinson and Company.