K212461 is an FDA 510(k) clearance for the VITEK MS PRIME. This device is classified as a Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II - Special Controls, product code QBN).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 15, 2022, 221 days after receiving the submission on August 6, 2021.
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 | K212461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2021 |
| Decision Date | March 15, 2022 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |