QBN
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3378
- Medical specialty
- Microbiology
- FDA 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.
- Adverse events (MAUDE)
- 2020: 54 · 2021: 163 · 2022: 135 · 2023: 39 · 2024: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495) | Bruker Daltonics GmbH & Co. KG | 2025-08-13 |
| VITEK MS PRIME (K212461) | bioMerieux, Inc. | 2022-03-15 |
| VITEK MS (K181412) | bioMerieux, Inc. | 2018-12-21 |
| MALDI Biotyper CA System (DEN170081) | Bruker Daltonik GmbH | 2018-04-20 |
Track QBN automatically
Every clearance here is in the API, with alerts when new ones post.