Laboratory_medicine
MALDI BIOTYPER CA (MBT-CA) SYSTEM
BRUKER DALTONICS, INC
FDA-cleared AI medical device
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
FDA Submission Metadata
- Submission number
- K130831
- Decision date
- November 2013
- FDA panel
- Microbiology
- Product code
- PEX
- Clinical task (npj)
- quantification/feature localization
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.