NEW YORK (GenomeWeb) – BioMérieux said today that the Vitek MS MALDI-TOF Mass Spectrometry System for rapid pathogen identification has received 510(k) clearance from the US Food and Drug Administration for the expanded identification of mycobacteria, Nocardia,and molds.
The company's database includes more than 15,000 distinct strains to provide high accuracy and enables the safe identification of the Mycobacterium tuberculosis (TB) group, the most frequent non-tuberculous mycobacteria (NTM), Nocardia, and the most medically important molds.
The company said that Vitek will offer efficient and reliable identification of these pathogens, providing clinicians with ways to manage infections such as tuberculosis, lung and bone infections, and other serious organ infections.
In order to gain FDA clearance for these new species, BioMérieux submitted information from a multi-center study consisting of 2,695 clinical isolates for 47 molds, 19 mycobacteria, and 12 Nocardia. FDA clearance of Mycobacterium species was from both solid and liquid growth media.
The competing Bruker MALDI biotyper system also received an expanded FDA approval today.