Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
The Mass Spectrometry, MALDI TOF, Microorganism Identification, Cultured Isolates device is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) technology for the identification and differentiation of microorganisms cultured from human specimens, used as a qualitative in vitro diagnostic aid in the diagnosis of bacterial and fungal infections in conjunction with other clinical and laboratory findings. It is classified as a Class 2 device under regulation 866.3378, requiring 510(k) premarket notification, and falls within the Microbiology (MI) medical specialty. The product code is QBN. It is not an implant and is not life-sustaining.
Research product code QBN in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QBN
- Device Class
- FDA class 2
- Regulation Number
- 866.3378
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251495 | MBT Compass HT CA Software; MBT FAST Shuttle US IVD | Aug 13, 2025 | Substantially Equivalent | Bruker Daltonics GmbH & Co. KG |
| K212461 | VITEK MS PRIME | Mar 15, 2022 | Substantially Equivalent | bioMerieux, Inc. |
| K181412 | VITEK MS | Dec 21, 2018 | Substantially Equivalent | bioMerieux, Inc. |
| DEN170081 | MALDI Biotyper CA System | Apr 20, 2018 | Unknown | Bruker Daltonik GmbH |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.