FDA-cleared MBT System for USA only

MALDI Biotyper CA System

FDA-cleared in the United States for identification of microorganism colonies cultured from human specimens

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.

The best technology from the experts in mass spectrometry

Being the leader in MALDI-TOF technology it is of great importance to Bruker to design robust, compact high performance platforms intended for extensive and routine use in the microbiology laboratory.

Bruker offers the MALDI Biotyper CA system with the microflex™ LT/SH microbial MALDI-TOF mass spectrometer with N2 laser providing a 60 Hz repetition rate or the high-end microflex™ LT/SH smart with Bruker's proprietary smartbeam™ solid state laser technology providing a 200 Hz repetition rate.

 

 

True benchtop solution

MALDI Biotyper is a low-noise operating system with low weight, requiring less than 3 feet of counter space, meeting laboratory needs for compact system solutions.

Easy to use

Intuitive software, WhisperMode™ for silent and pleasant operation.

High sensitivity

Resolution and sensitivity of the spectrometers are tailored to the needs of microbiologists. With the most sensitive detector technology available (FlashDetector™), users benefit from having the same high performance technology as large research grade instruments without the need for long and bulky instrument flight tubes.

Fast turn-around-time (TAT)

MALDI Biotyper systems offer the highest throughput for MALDI-TOF microbiology testing.

High accuracy

Greater than 98 percent accuracy compared to reference method 16S RNA sequencing in a multi-site clinical trial.

Highly reproducible results - run-to-run

The quick and simple Bacterial Test Standard (BTS) quality check performed before each run provides the highest standard of reproducibility.

Continuous operation

The self-cleaning MALDI PerpetualTM ion source permits continuous high performance with minimized maintenance requirements. Cleaning of the source using the separate IR-laser is performed easily under operator control.

Open Microbiology Concept

Open system with proven connectivity to a wide variety of lab devices.

Significant cost reduction

Studies show MALDI Biotyper costs are as much as 80 percent lower than conventional microbiology methods.