Waters announces FDA clearance of BD BACTEC FXI culture system for bloodstream infection diagnostics
Automated blood culture system improves detection speed and supports earlier sepsis diagnosis
24 Jun 2026Product news
BD BACTEC™ FXI Culture System
Waters Corporation has announced that the BD BACTEC™ FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance, enabling commercialization in the United States.
The fully automated blood culture system is designed to improve the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics in modern microbiology laboratories, providing a new option for clinical labs seeking to enhance patient care and antimicrobial stewardship.
Clinical study data1 showed that the BD BACTEC FXI Culture System reduced mean time to detection by approximately three hours (around 15%) compared with the previous-generation BD BACTEC™ FX Blood Culture System (17 hours versus 20 hours). Faster detection supports earlier pathogen identification and more timely targeted antimicrobial therapy for patients with suspected bloodstream infections and sepsis.
Recent evidence-based laboratory guidelines highlight the clinical benefits of rapid laboratory results for the detection of bloodstream infections and sepsis. These guidelines emphasize that advancing the science of automated blood culture instruments is critical to further accelerating result turnaround times. By shortening time to detection, the BD BACTEC FXI Culture System is intended to help clinicians act sooner with evidence-based treatment decisions.
Automated gravimetric blood volume measurement to reduce variability
The BD BACTEC FXI Culture System introduces a first-of-its-kind capability in a blood culture platform: automated gravimetric measurement of individual blood culture vial volume. By objectively confirming the blood volume in each vial, the system is designed to reduce pre-analytical variability and support more consistent diagnostic performance.
This automated volume verification also supports adherence to recommended blood collection practices, which can influence the sensitivity of blood culture testing and the reliability of bloodstream infection detection.
High-throughput automation and increased vial capacity
Engineered for high-throughput microbiology laboratories, the BD BACTEC FXI Culture System fully automates vial loading, unloading, incubation, and detection alerts. The system offers an automated loading capacity of up to 60 vials at a time2 to maximize staff walk-away time and reduce manual handling.
The BD BACTEC FXI Culture System is available in 480- and 960-vial configurations2, providing scalable options for laboratories with varying test volumes. The increased capacity and automation are designed to support efficient workflows, reduce manual intervention, and help laboratories manage growing demand for sepsis and bloodstream infection diagnostics.
Waters’ commitment to advancing bloodstream infection diagnostics
Waters Corporation, through its Waters Advanced Diagnostics business, is focused on delivering technologies that support earlier and more confident clinical decision-making. The BD BACTEC FXI Culture System reflects this commitment by combining faster time to detection with advanced automation and standardized blood volume measurement.
By enabling laboratories to deliver more timely and consistent blood culture results, the system is intended to support improved patient outcomes in cases of suspected sepsis and other bloodstream infections, where every hour can be critical.
Global regulatory milestones for BD BACTEC FXI Culture System
In addition to FDA 510(k) clearance in the United States, the BD BACTEC FXI Culture System has been CE marked under the European Union’s In Vitro Diagnostic Regulation (IVDR) and licensed by the Japan Pharmaceuticals and Medical Devices Agency (PMDA). These regulatory milestones support availability of the system in Europe and Japan, expanding global access to advanced automated blood culture diagnostics.
References
1. Data on file BD, Clinical Performance Study Report IDS-23BACT002. Overall faster mean time to detection 2.8-hrs – 3.2-hrs compared to BD BACTEC FX Blood Culture System for BD BACTEC™ Plus Aerobic media and BD BACTEC™ Lytic Anaerobic media, respectively.
2. Specification Data on File, Becton, Dickinson and Company 2026.
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Frequently asked questions
What is the BD BACTEC FXI Culture System and what recent FDA milestone has it achieved in the United States?
The BD BACTEC FXI Culture System is a fully automated blood culture platform designed for sepsis and bloodstream infection diagnostics in microbiology laboratories. Waters Corporation announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance, enabling commercialization in the United States and supporting improved patient care and antimicrobial stewardship.
How does the BD BACTEC FXI Culture System improve time to detection and support sepsis management?
Clinical study data show the BD BACTEC FXI Culture System reduces mean time to detection to 17 hours, about three hours faster than the previous BD BACTEC FX system. Faster detection enables earlier pathogen identification and more timely targeted antimicrobial therapy, which is critical because each hour of delayed sepsis treatment is associated with a 3.6% to 9.9% increase in mortality.
What advanced automation and global regulatory approvals distinguish the BD BACTEC FXI Culture System in blood culture diagnostics?
The BD BACTEC FXI Culture System offers automated gravimetric blood volume measurement, high-throughput vial loading of up to 60 vials at a time, and 480- or 960-vial configurations. It has FDA 510(k) clearance in the U.S., CE marking under the EU IVDR, and licensing by Japan’s PMDA, expanding access to advanced automated blood culture diagnostics worldwide.