QBN — Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Class II
Classification Details
- Product Code
- QBN
- Device Class
- Class II
- Regulation Number
- 866.3378
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms 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 in the diagnosis of bacterial and fungal infections.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251495 | bruker daltonics gmbh and co. kg | MBT Compass HT CA Software; MBT FAST Shuttle US IVD | August 13, 2025 |
| K212461 | biomerieux | VITEK MS PRIME | March 15, 2022 |
| K181412 | biomerieux | VITEK MS | December 21, 2018 |
| DEN170081 | bruker daltonik | MALDI Biotyper CA System | April 20, 2018 |