FDA has recently granted premarket notification (510(k)) clearance for a library and methods expansion of the MALDI Biotyper CA system by Bruker, Billerica, Mass, which is sold in the United States for clinical microbiology.

The MALDI Biotyper platform achieves classification and identification of microorganisms using proteomic fingerprinting by high-throughput matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry. MALDI Biotyper applications include routine clinical microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing, and quality control, as well as veterinary microbiology.

FDA granted Bruker’s first 510(k) clearance for the MALDI Biotyper CA system in November 2013. Approved for in vitro diagnostic applications, the system included Bruker’s MALDI Biotyper mass spectrometry 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 recent clearance of a second, expanded claim adds 170 species and species groups representing 180 clinically relevant species of aerobic Gram-positive bacteria, fastidious Gram-negative bacteria, Enterobacteriaceae, anaerobic bacteria, and yeasts. In addition, customers will have additional specimen preparation options to further optimize workflows.


Frank H. Laukien, PhD, Bruker Corp.

“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,” says Frank H. Laukien, PhD, president and CEO of Bruker Corp. “The most recent 510(k) clearance for the MALDI Biotyper CA system further expands its clinical utility by offering the largest FDA-cleared library for expedited, high-accuracy identification of bacteria and yeasts. This latest clearance allows an even larger segment of US hospitals and clinical microbiology laboratories to adopt this revolutionary technology for serving their infectious disease physicians and patients, and opens the door for making it the new standard of care.”

As a result of the latest 510(k) clearance, the MALDI Biotyper CA system can now 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.

In its 510(k) submission to FDA, Bruker submitted data from its recent multicenter clinical trials, comprising more than 10,000 spectra. Results generated by the MALDI Biotyper CA system were compared to 16S ribosomal RNA molecular sequencing for bacteria, and internal transcribed spacer sequencing for yeasts. The results were supplemented by protein gene sequencing, which demonstrated that 98.9% of the tested isolates resulted in correct identifications to the genus or species level, with only 0.9% of isolates unable to be identified. This is the highest level of identification accuracy reported for any mass spectrometry-based bacterial and yeast identification system.

For more information, visit Bruker Corp.