U.S. FDA Clearance for Mass Spectrometry

Recommendation

25-27 June 2024
Munich, Germany

European Microbiology Conference 2024

bioMérieux announced that it has been granted U.S. FDA 510(k) de novo clearance for VITEK® MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. VITEK® MS is the latest addition to the VITEK® family of products, and it is the first system to enable detection of disease causing microorganisms in minutes: this game-changing technology can significantly improve patient care. The Cleveland Clinic recently named the technique as one of the Top Ten Breakthrough Medical Technologies of 2013.

To gain FDA clearance bioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates. VITEK® MS accuracy was compared to 16S Ribosomal RNA gene sequencing, the gold standard, for the following categories of microbial pathogens: anaerobic bacteria, Enterobacteriaceae, Gram-positive aerobes, fastidious Gram-negative bacteria, Gram-negative non-Enterobacteriaceae and yeast. The overall accuracy of VITEK® MS compared to nucleic acid sequencing for these organisms was 93.6 percent.

More details please see the bioMérieux news release.