BioMérieux has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vitek Reveal AST system, which reports antimicrobial susceptibility testing (AST) results directly from positive blood cultures.
The clearance allows the U.S. commercialization of Vitek Reveal. The FDA had previously granted breakthrough device designation to the system in 2022. Vitek Reveal is also CE-marked under the European Union's in vitro device directive (for its reagents) and in vitro diagnostic regulation (for the instrument).
The system, part of BioMérieux’s portfolio of diagnostics for bloodstream infections and sepsis, can deliver actionable results for gram-negative bacteria directly from positive blood cultures in about 5.5 to 6 hours, thus enabling same-day treatment decision-making for patients with bacteremic sepsis, according to a statement from the company.
According to BioMérieux, the project has been funded in part with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
