Bruker's MALDI Biotyper Gets FDA Clearance to Identify Gram Negatives

Bruker Corporation has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

The MALDI Biotyper CA System includes the 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. Bruker has conducted a multi-site clinical trial comparing performance of the MALDI Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper CA System is the latest achievement in Bruker's continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.

In 2009, Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive EC/98/79, making the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF based product registered for use in European clinical microbiology laboratories. Since then, Bruker has continued to expand into routine clinical microbiology and other markets throughout the world. Currently there are more than 1,000 systems sold or leased worldwide.