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bioMérieux seeks FDA approval for BacT/Alert Virtuo automated blood culturing system

MDBR Staff Writer Published 03 August 2016

In vitro diagnostics solutions provider bioMérieux is seeking approval from the US Food and Drug Administration (FDA) for its BacT/Alert Virtuo automated blood culturing system.

The company has submitted an application with the FDA for 510(k) clearance for the system, which is based on the BacT/Alert product range with new capabilities.

BacT/Alert Virtuo is claimed to be the only continuously monitoring blood culture microbial detection system to provide Load & Go technology.

The new blood culture system can aggregate 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. It allows to manage high volumes of up to 100,000 bottles/year with a single entry point.

Bottles will be 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.

bioMérieux Americas vice president and CEO Stefan Willemsen said: "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.

"Greater integration, workflow and speed to results are critical for managing sepsis and controlling antimicrobial resistance.”