US-based Bruker has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its MALDI Biotyper CA system to identify Gram negative bacterial colonies cultured from human specimens.
Bruker’s MALDI Biotyper CA system comprises bench-top microflex MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra.
The company has conducted a clinical study comparing the accuracy of MALDI Biotyper CA system to 16S ribosomal RNA gene sequencing. This study demonstrated positive results for the MALDI Biotyper CA system.
Bruker president and CEO Frank Laukien noted the company is very excited about this major milestone in its efforts to introduce MALDI-TOF mass spectrometry into clinical diagnostics.
"For the last seven years Bruker has been working on continuous innovation in the field of MALDI-TOF-based microbial identification, bringing the MALDI Biotyper platform into clinical routine laboratories. The MALDI Biotyper has been a success with more than 1,000 systems sold or leased worldwide, which has positively affected the health of many patients.
"Bruker has initiated a continuing revolution in clinical microbiology towards the MALDI Biotyper as a next-generation identification technique. With clearance by the US FDA to market the MALDI Biotyper CA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare," Laukien added.
Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive in 2009.
Using a molecular approach based on specific proteomic fingerprints, the MALDI Biotyper family of systems allows molecular identification, and taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi.
Applications of the various MALDI Biotyper solutions include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology.
The products of the MALDI Biotyper family are available in a research-use-only version, as the FDA-cleared MALDI Biotyper CA system, or in an IVD-CE version according to EU directive.