Waters' BD BACTEC FXI Secures FDA Clearance With 15% Faster Detection, 50% More Throughput
WAT•Waters' BD BACTEC FXI Culture System received FDA 510(k) clearance, enabling U.S. commercialization of the fully automated platform with up to 960-vial modules and 50% higher loading capacity. Clinical data show a 3-hour (15%) faster time to detection versus the prior model, enhancing early sepsis diagnostics.
1. FDA Clearance and Commercialization
Waters Corporation announced FDA 510(k) clearance of the BD BACTEC FXI Culture System, authorizing U.S. market launch of its fully automated blood culture solution for sepsis and bloodstream infection diagnostics.
2. Improved Diagnostic Performance
Clinical trial data demonstrated a mean time to detection of 17 hours versus 20 hours for the previous-generation system—a 3-hour (15%) reduction, enabling earlier pathogen identification and targeted antimicrobial therapy.
3. Enhanced Automation and Capacity
The FXI system features automated gravimetric vial volume measurement and offers a 50% increase in vial loading capacity—up to 960 vials per module—maximizing laboratory walk-away time and consistency.
4. Global Regulatory Approvals
Prior to U.S. clearance, the system obtained CE marking under IVDR in Europe and licensing by Japan’s PMDA, positioning Waters for broader adoption in high-throughput microbiology laboratories.
