Waters BD BACTEC FXI FDA Clearance

Oracle Corporation announced that its BD BACTEC FXI Culture System has received U.S. United States — Food and Drug Administration 510(k) clearance, enabling its commercialization in the United States. This fully automated blood culture system is designed to improve the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics. Clinical study data showed a three-hour faster time to detection compared to the previous generation system, which is crucial given that delayed sepsis treatment increases mortality. The system also features automated gravimetric measurement of blood culture vial volume, reducing pre-analytical variability. The BD BACTEC FXI Culture System has an industry-leading automated loading capacity and is available in 480- and 960-vial configurations. It had previously received CE mark under the European Union's In Vitro Diagnostic Regulation and was licensed by the Japan — Pharmaceuticals and Medical Devices Agency for availability in Europe and Japan. BD (company) remains the legal manufacturer of the product during a transition period following the acquisition of its Biosciences and Diagnostic Solutions businesses by Oracle Corporation.