FDA Grants Bruker’s MALDI Biotyper CA System Second, Expanded Claim

Bruker’s MALDI Biotyper CA System, an in vitro diagnostic for clinical microbiology, has received 510(k) clearance for library and methods expansion, the Billerica, Mass., company announced Friday.

The expansion means that the system can identify 210 species or species groups, spanning 280 bacteria and yeast species, and covering more than 98 percent of the typical bacteria identification workflow of clinical microbiology laboratories, the devicemaker said.

A multicenter clinical trial, consisting of more than 10,000 spectra, demonstrated that the MALDI Biotyper CA System’s results showed that 98.9 percent of the isolates tested yielded a correct identification to the genus or species level, with only 0.9 percent of isolated unidentified. This is the highest identification accuracy for any mass spectrometry-based bacterial and yeast identification system, the company said.

The system boasts the largest FDA-cleared library for bacteria and yeast identification, added Bruker President and CEO Frank H. Laukien, Ph.D.

The MALDI Biotyper CA System operates by using Matrix Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry to establish an organism’s unique molecular fingerprint. It received FDA clearance in 2013.

The similar IVD MALDI Biotyper System received both the CE Mark and Chinese Food and Drug Administration clearance in 2009 and 2014, respectively. — Jason Scott