The Food and Drug Administration (FDA) has expanded 510(k) clearance for bioMérieux’s Vitek MS instrument to include identification of the Mycobacterium tuberculosis group, the most frequent non-tuberculous mycobacteria, and the most medically important molds. The Vitek MS is a matrix-assisted laser desorption/ionization-time of flight mass spectrometry system for rapid pathogen identification. With this new clearance, its database now includes more than 15,000 distinct pathogen strains. To gain FDA clearance for these species, bioMérieux submitted data from a multi-center study consisting of 2,695 clinical isolates for 47 molds, 19 mycobacteria, and 12 Nocardia. FDA clearance of mycobacteria species was from both solid and liquid growth media. For cases in which microorganisms are resistant to carbapenems, bioMérieux has also developed and received FDA clearance for its Rapidec Carba NP test that enables detection of carbapenemase producers within 2 hours.