FDA-cleared MBT System for USA only

MALDI-TOF Mass Spectrometry for Fast, Accurate and Effective Microbial Identification

The market-leading Bruker MALDI Biotyper system has quickly revolutionized the way microbial identification is performed

MALDI Biotyper CA System FDA-cleared for USA only

The speed, accuracy, ease of use and cost efficiency are so impressive that an ever increasing number of clinical laboratories all over the world already employ this system solution for the identification of microorganisms.

The MALDI Biotyper CA System has been granted USA FDA clearance under Section 510(k) for the identification of Gram negative and Gram positive bacteria, anaerobic bacteria and yeast cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid the diagnosis of bacterial and yeast infections.

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.

Identifying microorganisms by their molecular fingerprint

The Bruker MALDI Biotyper CA System identifies microorganisms using MALDI-TOF Mass Spectrometry to determine the unique protein fingerprint of an organism.
Specifically, the MALDI Biotyper CA System measures highly abundant proteins that are found in all microorganisms. The characteristic patterns of these proteins are used to reliably and accurately identify a particular microorganism by matching it against the FDA-cleared library.

 

The microorganism reference library

The MALDI Biotyper CA System can identify 333 species or species groups, covering 424 clinically relevant bacteria and yeast species, and representing more than 98% of the typical bacterial identification workflow of clinical microbiology laboratories.

 

A complete system solution

The MALDI Biotyper CA System includes Bruker’s MALDI-TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) benchtop microflex™ LT/SH mass spectrometer or the high-end microflex™ LT/SH smart, software, IVD labeled reagents, a disposable MBT Biotarget 96 or a reusable 48-spot MALDI target plate and the FDA-cleared microorganism reference library (click here to download the list). 

Your benefits

  • Accuracy comparable to Nucleic Acid Sequencing
  • Applicable to a wide range of microorganisms
  • Much faster than traditional identification methods
  • Robust and easy to use
  • True benchtop system
  • Cost-effective
  • With optional additional workflow tools to improve productivity and standardization
Identifying microorganisms by their proteomic fingerprint

MALDI Biotyper CA System is available in the USA only