BacT/ALERT® VIRTUO™ gets FDA 510(k) certification

At Marcy l'Étoile (France) - April 6, 2017 - bioMérieux, a longtime researcher in the field of in vitro diagnostics and a pioneer in microbiology, announced that the automated blood culture system fully active BacT / ALERT® VIRTUO™ has achieved 510(k) certification from the US Food and Drug Administration (FDA)

BioMérieux receives FDA 510(k) certification for BacT/ALERT® VIRTUO™ automated blood culture system

At Marcy l'Étoile (France) - April 6, 2017 - bioMérieux, a longtime researcher in the field of in vitro diagnostics and a pioneer in microbiology, announced that the automated blood culture system fully active BacT / ALERT® VIRTUO™ has achieved 510(k) certification from the US Food and Drug Administration (FDA). This new bacterial detection system is currently being commercialized in countries where the CE mark is recognized.

BacT / ALERT® VIRTUO™ is the first continuous blood bacterial detection system to offer "Load & Go" technology, helping laboratories streamline their workflow. Staff of different skill levels can easily load bottles on the machine at any time of the day and night, allowing for rapid incubation and reduced practice time. Bottles are disposed of fully automatically with light and sound alarms.

BacT/ALERT® VIRTUO™ offers proprietary algorithms, stable at high temperature and brightness that increase blood culture efficiency to reduce detection time. This enables faster identification of blood infections.

This superior blood culture system supports the BacT/ALERT® product line. It offers an integrated configuration with scalability from 428 to 1,712 cells and facilitates the management of high volumes of blood culture bottles.

Proprietary blood level detection technology measures the amount of blood in each blood culture bottle at the time of bottle loading. This feature helps laboratories monitor and ensure blood volume collection in accordance with quality control procedures such as CAP standards. This is a significant benefit when caring for patients, as blood collection is an important factor in the detection of sepsis.

"We are proud to receive the  FDA approval for BacT / ALERT® VIRTUO ™, which allows us to increase our product offering to US customers," said François Lacoste, VP of clinical practice at bioMérieux. "This highly automated blood culture solution enables rapid detection of pathogens for clinical microbiology laboratories, which is critical for optimal patient treatment, especially in threatening conditions. life-threatening as sepsis can progress to severe sepsis.

BacT / ALERT® VIRTUO™ uses  FAN® Plus medium designed to optimize antibiotic neutralization with optimal microbial growth activity. These proven blood culture bottles are manufactured at bioMérieux's facility in Durham (NC), where the Company recently invested in additional blood culture bottle production lines.

With BacT/ALERT® VIRTUO™, VITEK® and FilmArray®, bioMérieux offers advanced integrated microbiology solutions to streamline laboratory workflows and improve efficiency. These integrated solutions deliver faster, reliable and meaningful results for clinicians, leading to improved patient care.