bioMérieux’s AST System VITEK REVEAL receives US FDA 510(k) clearance

bioMérieux, a world leader in in vitro diagnostics, has announced that its VITEK^® REVEAL™ AST System, reporting results directly from positive blood cultures, has received US Food and Drug Administration (FDA) 510(k) clearance.

As part of its commitment to combat sepsis and AMR, in 2022 bioMérieux acquired Specific Diagnostics, a US based company that has developed an AST system now called VITEK^® REVEAL™. The instrument integrates into bioMérieux’s portfolio of diagnostic solutions to address bloodstream infections and sepsis.

The modular VITEK^® REVEAL™ AST system can deliver actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours^1,2 enabling same-day treatment decision-making for patients with bacteremic sepsis.

The FDA 510(k) clearance allows the commercialization of VITEK^® REVEAL™ in the United States. In August 2022, the FDA granted the system with its Breakthrough Device Designation, which is reserved for medical devices that offer significant advantages over existing cleared alternatives, for which no approved alternatives exist, and/or for which device availability is in the best interest of patients³. This AST system is also CE-marked under IVDD* (reagents) and IVDR** (instrument) in Europe.

“VITEK^® REVEAL™ is fully aligned with bioMérieux’s priority to provide innovative diagnostics to support antimicrobial stewardship. By integrating this advanced technology in bioMérieux’s portfolio, we are increasing the ability of laboratories to deliver AST results as soon as possible, especially in cases of critical bacteremia-associated sepsis, which require urgent and appropriate treatment.” added Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer.

This project has been funded in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA).

References
1. Rottman M., Rhodes P.A., Singh P., Herrmann J.L., Jeannot K., Cattoir V., Carbonnelle E., Plesiat P., Williams A., Dortet L. Clinical evaluation of the SPECIFIC REVEAL™ Rapid AST System with Gram-negative bacteremia samples in 6 hospitals in France and England. Poster presented at: 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID); 2022 May; Lisbon, Portugal.
2. BMX.1.129899 Clinical Trial Summary Report (proprietary, on file at bioMérieux).
3. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

* In Vitro Diagnostic Directive.
** In Vitro Diagnostic Regulation.

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