Bruker Announces FDA Clearance of Claims 7 and 8 for theMALDI Biotyper® CA System, Expanding Diagnostic Capabilities

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Bruker Announces FDA Clearance of Claims 7 and 8 for theMALDI Biotyper® CA System, Expanding Diagnostic Capabilities

Claim 7: FDA clearance of MBT FAST™ Shuttle US IVD and MBT Compass HT CA software improves workflow efficiency and accelerates data processing.
Claim 8: FDA approval of expanded reference library increases coverage to 549 validated microbial species.

At the annual IDWeek meeting (https://idweek.org/), Bruker announced the U.S. Food and Drug Administration (FDA) clearance of Claim 7 and Claim 8 for its MALDI Biotyper^® CA System, marking a significant advancement in clinical microbial identification capabilities. The clearance includes the MBT Compass HT CA software and MBT FAST™ Shuttle US IVD (Claim 7), as well as a major expansion of the FDA-cleared reference library (Claim 8), now encompassing 549 clinically validated microbial species across gram-positive and gram-negative bacteria, anaerobes and yeasts.

Technology Enhancements

The MALDI Biotyper CA System is a mass spectrometry-based platform that uses MALDI-TOF technology for rapid identification of microorganisms following culture from human specimens, either from isolated colonies or positively flagged blood cultures. With the newly cleared MBT Compass HT CA software, laboratories benefit from enhanced performance, including parallel data processing, improved user management, and support for 21 CFR Part 11 compliance. It also features IDealTune, an automated tuning function that maintains optimal system performance by continuously monitoring the US IVD Bacterial Test Standard quality control results. This reduces the need for manual tune-ups and ensures consistent diagnostic reliability over extended periods.

The MBT FAST Shuttle US IVD enables accelerated drying of droplets, including MALDI matrix, hence significantly reducing sample preparation time as compared to room temperature drying. In addition to speed, it also standardizes sample preparation, resulting in reproducible matrix crystallization – a critical factor in MALDI-TOF analysis. This consistency further improves sample preparation quality which can contribute to more reliable and accurate identification results.

Expanded Diagnostic Reach

The FDA-cleared reference library now includes reference spectra of 549 clinically validated microbial species in 437 groups, covering gram-positive and gram-negative bacteria, anaerobes, and yeasts. Additionally, the system includes over 3400 non-clinically validated species, which are clearly marked in reports to guide alternate identification methods. These results are not transmitted to the laboratory information system, ensuring clarity and compliance in reporting.

Outlook

Looking ahead, Bruker is finalizing internal processes to prepare for shipment of the updated MALDI Biotyper CA System in the U.S. and Puerto Rico. In addition to new system deliveries, current users of the MALDI Biotyper CA System can also benefit from the newly FDA-cleared features – the updated reference library, MBT FAST Shuttle US IVD, and MBT Compass HT CA software – to expand the capabilities of their existing systems. The company continues to invest in expanding its validated library and software capabilities, with future claims expected to further enhance diagnostic reach and efficiency.