510(k) K212461
K212461 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VITEK MS PRIME". The FDA issued a decision of Substantially Equivalent on March 15, 2022. The device falls under product code QBN (Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates), a Class II device regulated under 21 CFR 866.3378. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2022
- Date Received
- August 6, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Device Class
- Class II
- Regulation Number
- 866.3378
- Review Panel
- MI
- Submission Type
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.