Cleared Traditional

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

K251495 · Bruker Daltonics GmbH & Co. KG · Microbiology
Aug 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K251495 is an FDA 510(k) clearance for the MBT Compass HT CA Software; MBT FAST Shuttle US IVD, a Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II — Special Controls, product code QBN), submitted by Bruker Daltonics GmbH & Co. KG (Bremen, DE). The FDA issued a Cleared decision on August 13, 2025, 90 days after receiving the submission on May 15, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3378.

Submission Details

510(k) Number K251495 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2025
Decision Date August 13, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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.