DEN170081 is an FDA 510(k) submission for the MALDI Biotyper CA System. This device is classified as a Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II - Special Controls, product code QBN).
Submitted by Bruker Daltonik GmbH (Bremen, DE). The FDA issued a Not Cleared (DENG) decision on April 20, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3378. 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) Number | DEN170081 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2017 |
| Decision Date | April 20, 2018 |
| Days to Decision | 203 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | QBN - Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3378 |
| 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. |