FDA product code QBN: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QBN is the FDA product code for mass spectrometry, maldi tof, microorganism identification, cultured isolates. It is a Class II device, regulated under 21 CFR 866.3378 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QBN, 2 in the last five years, from 2 different applicants. The average 510(k) review took 172 days (median 205); 90 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device class | Class II |
| Regulation | 21 CFR 866.3378 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 205 |
| 2022 | 1 | 221 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every QBN clearance
Top QBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| bioMerieux, Inc. | 2 | 2022-03-15 |
| Bruker Daltonics GmbH & Co. KG | 1 | 2025-08-13 |
Most recent QBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251495 | Bruker Daltonics GmbH & Co. KG | MBT Compass HT CA Software; MBT FAST Shuttle US IVD | 2025-08-13 | 90 |
| K212461 | bioMerieux, Inc. | VITEK MS PRIME | 2022-03-15 | 221 |
| K181412 | bioMerieux, Inc. | VITEK MS | 2018-12-21 | 205 |
Recalls for QBN devices
openFDA lists no recalls for product code QBN.
Frequently asked questions
What is FDA product code QBN?
QBN is the FDA product code for mass spectrometry, maldi tof, microorganism identification, cultured isolates. It is a Class II device, regulated under 21 CFR 866.3378 and reviewed by the Microbiology panel.
What device class is QBN?
Class II, regulation 21 CFR 866.3378. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBN?
Across 3 cleared submissions the average was 172 days from receipt to decision (median 205).
Which companies have the most QBN clearances?
bioMerieux, Inc. (2); Bruker Daltonics GmbH & Co. KG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBN
- Run a recall and safety report across every QBN manufacturer
- Watch product code QBN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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