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

bioMérieux

The new system demonstrates bioMérieux’s commitment to automated blood culture - a foundational step to infectious disease diagnosis

2 Aug 2019
Alex Waite
Editorial Assistant

Product news

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).


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Cell / Tissue CultureCell culture or tissue culture is used to study the biology of cells or tissues and to isolate cellular products in an environment which can be manipulated and well defined. Accurately control your culture environment with bioreactors or culture incubators, bind your cells to a surface or together with an extracellular matrix. Distinguish cell types with differential media or proliferate cells with certain characteristics using selective media. Enrich your media with supplements such as growth factors, sera and vitamins. Find the best cell and tissue culture products, kits and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Blood TransfusionBlood Transfusion involves giving donor blood to a recipient patient. Screening is essential to avoid transfusion reactions. Blood banks use immunohematological techniques to determine rh and ABO blood group, and screen for antibodies using specific antisera. Blood Banks use Direct Coombs Tests (DCT) and Indirect Coombs Tests (IAT) to detect hemolysis and Haemolytic Disease of the Newborn (HDN).HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.AACCThe American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo is the largest meeting for clinical laboratory professionals in the world. This year's meeting is being held in Atlanta, USA, July 26th-30th, 2015.AutomationAutomation in laboratories and manufacturing processes enhances efficiency, precision, and scalability by reducing the need for manual intervention. It plays a critical role in improving productivity, minimizing human error, and accelerating workflows in fields like diagnostics, drug development, and industrial testing. Automation technologies include robotic systems, automated liquid handlers, and process control systems that streamline complex tasks and ensure consistent, reproducible results. Explore our peer-reviewed product directory to discover the best automation solutions, compare options, read user reviews, and get prices directly from manufacturers.Blood CollectionMicrobial DetectionMicrobial detection is crucial for identifying and quantifying bacteria, viruses, fungi, and other microorganisms. This process is essential for food safety, environmental monitoring, clinical diagnostics, and pharmaceutical manufacturing. Explore the best microbial detection tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Blood AnalysisThe analysis of blood is vital for many areas of life sciences and forensic investigations. Blood samples can be tested for a number of different reasons such as diagnosis, glucose levels, cholesterol and drug testing.Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

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