Bruker Gets FDA Clearance For Library And Methods Expansion For MALDI System

(RTTNews) - Bruker (BRKR) announced it has received 510(k) clearance from the US FDA for library and methods expansion for the MALDI Biotyper CA System, sold in the U.S. for clinical microbiology. The recent clearance now adds 170 species and species groups, representing 180 clinically-relevant species of aerobic Gram positive, fastidious Gram negatives, Enterobacteriaceae, anaerobic bacteria and yeasts.

As a result of the latest 510(k) clearance, the MALDI Biotyper CA System can now in total identify 210 species or species groups, covering 280 clinically relevant bacteria and yeast species, and representing more than 98% of the typical bacterial identification workflow of clinical microbiology laboratories.