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510(k) K251495

MBT Compass HT CA Software; MBT FAST Shuttle US IVD by Bruker Daltonics GmbH & Co. KG — Product Code QBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2025
Date Received
May 15, 2025
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.

Other clearances for product code QBN

  • K212461 — VITEK MS PRIME (March 15, 2022)
  • K181412 — VITEK MS (December 21, 2018)
  • DEN170081 — MALDI Biotyper CA System (April 20, 2018)