bioMérieux Submits 510(k) Application to the FDA for BacT/ALERT® VIRTUO™ Next Generation Automated Blood Culture System

bioMérieux, a world leader in the field of in vitro diagnostics, announces that BacT/ALERT^® VIRTUO™, the next generation of BacT/ALERT^® automated blood culturing system, has been submitted to the U.S. Food and Drug Administration for 510(k) clearance.

This automated blood culture microbial detection system builds on the features provided by the BacT/ALERT^® product range with new capabilities. BacT/ALERT^® VIRTUO™ is only commercially available in countries that recognize CE-marking.

BacT/ALERT^® VIRTUO™ is the first continuously monitoring blood culture microbial detection system to offer “Load & Go” technology. Unloading the device is fully automated with visual and audible alarms and alerts.

“BacT/ALERT^® VIRTUO™ is intended to improve integration of the blood culture work flow within the microbiology lab. Blood culturing for microbial detection is such an essential step in the process of pathogen identification,” said Stefan Willemsen, VP Americas and CEO of bioMérieux Inc. “Greater integration, workflow and speed to results are critical for managing sepsis and controlling antimicrobial resistance. Efficiency in the microbiology lab starts with blood culturing for microbial detection, so it is our goal to continuously improve upon this process.”

This blood culture system can combine up to three additional incubators subunits connected to a command module in a single BacT/ALERT^® VIRTUO™ bank. A BacT/ALERT^® VIRTUO™ bank is an integrated configuration, scalable from 428 to 1,712 cells capacity and enables the management of high volumes of up to 100,000 bottles/year with a single entry point. Bottles are automatically transferred into the system and a Blood Level Detection feature measures the blood volume in each blood culture bottle at the time of loading. This feature is meant to help track and ensure collection of the recommended blood volume.

The BacT/ALERT^® VIRTUO™ system utilizes proven blood culture media bottles. BacT/ALERT^® blood culture media offers an ideal environment for recovering an array of microorganisms, including bacteria, fungi, and mycobacteria. This offering includes the recently launched BacT/ALERT^® FAN^® Plus bottles (aerobic, anaerobic and pediatric), which use proprietary Adsorbent Polymeric Beads (APB).