Bruker has obtained 510(k) approval from the US Food and Drug Administration (FDA) for expanded claim of the MALDI Biotyper CA system.
Approved for library and methods expansion, the system is used for clinical microbiology in the US.
The latest approval allows the company to provide 170 species and species groups for customers, including 180 clinically-relevant species of aerobic Gram positive, fastidious Gram negatives, Enterobacteriaceae, anaerobic bacteria and yeasts.
Bruker president and CEO Frank Laukien said: "The MALDI Biotyper has changed the paradigm of bacterial identification worldwide due to its dramatically faster time-to-result, exceptional identification performance, ease of use, cost effectiveness and robust, compact instrumentation."
In addition, the company will provide an additional specimen preparation options for customers, in a bid to enhance workflows.
In November 2013, the company received 510(k) approval for a first claim of the system, an IVD solution, which comprised firm’s MALDI Biotyper instrumentation, software, a library of 40 aerobic Gram negative bacterial species or species groups, covering 100 clinically relevant species; in vitro diagnostic reagents; and standard operating procedures.
The applications of the MALDI Biotyper include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing, and quality control, as well as veterinary microbiology.
With the current approval, the MALDI Biotyper CA System can now identify 210 species or species groups, covering 280 clinically relevant bacteria and yeast species.
The company recently submitted data from multi-center studies to the FDA that included more than 10,000 spectra, and results generated by the system were compared to 16s rRNA molecular sequencing for bacteria and ITS sequencing for yeasts.
Supplemented by protein gene sequencing, the studies demonstrated that 98.9% of the isolates tested have resulted in correct identifications to the genus or species level, according to the company.
Image: Rod-shaped gram-positive Bacillus anthracis bacteria in a cerebrospinal fluid sample stand out from round white blood cells. Photo: courtesy of Yuval Madar.