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BioMérieux Gets FDA 510(k) Clearance for MALDI-TOF Bacterial ID System

NEW YORK – BioMérieux said on Friday that it has received 510(k) clearance from the US Food and Drug Administration for its Vitek MS Prime MALDI-TOF mass spectrometry identification system.

The Vitek MS Prime was CE marked last year and is commercially available in countries that recognize the CE mark, some Asian and Latin American countries, and now in the US, BioMérieux said in a statement.

The compact, benchtop system is the next generation of the firm's Vitek MS system, offering improved automation for routine microbial identification in minutes as well as greater lab workflow efficiency. The system integrates with the Vitek 2 for antimicrobial susceptibility testing as well as with Myla middleware for data integration. 

"Extensive lab input was incorporated into the development of Vitek MS Prime, so we know the unique and differentiating features like prioritization of urgent samples and continuous 'load and go' will be valued," Brian Armstrong, BioMérieux's senior VP of clinical operations for North America, said in a statement. 

Pierre Boulud, chief operating officer of clinical operations for BioMérieux, said that in the past six months the adoption rate for the system in Europe has been "astounding," adding that "extending access to the US means even more labs can benefit from providing critical information more rapidly to clinicians so more effective antimicrobial therapy is prescribed sooner." 

BioMérieux said it plans to extend the commercial launch of Vitek MS Prime globally throughout 2022.