NEW YORK (GenomeWeb) – Bruker said today that it has received 510(k) clearance from the US Food and Drug Administration for an expanded version of its MALDI Biotyper clinical microbiology system.
The expansion adds 170 species and species groups representing 180 clinically relevant species of aerobic gram-positive bacteria, fastidious gram negatives, Enterobacteriaceae, anaerobic bacteria, and yeasts, as well as new specimen preparation options, the company said.
Adding the library covered by FDA's initial clearance of the MALDI Biotyper, which included 40 aerobic gram-negative bacterial species or species groups covering 100 clinically relevant species, the system is now FDA-cleared to identify 210 species or species groups covering 280 clinically relevant bacteria and yeast species. According to Bruker, the library now covers more than 98 percent of the typical bacterial identification workflow of clinical microbiology laboratories.
The clearance pulls Bruker's offerings closer to those of its main competition in the MALDI-based clinical microbiology space, BioMérieux, whose Vitek MS system received FDA clearance in August 2013, several months before the MALDI Biotyper. While the Biotyper's initial FDA-cleared libraries covered only aerobic gram-negative bacteria, the Vitek MS had cleared libraries covering gram-negative bacteria, gram-positive bacteria, yeast, and anaerobes.
Both the Biotyper and Vitek MS platforms identify microbes by matching the protein profiles of sample organisms generated via MALDI mass spec to profiles contained in proprietary databases. Compared to traditional biochemical methods of microbe detection, MALDI-based systems can offer significant improvements in speed, price, and accuracy.
For this recent 510(k) submission, Bruker provided FDA with data from multicenter studies investigating the device, comparing its performance to that of 16s rRNA sequencing for bacteria and TS sequencing for yeast. According to the company, their results found that 98.9 percent of tested isolates were identified correctly at either the genus or species level, while the system was unable to identify only .9 percent of isolates.