FDA Product Code QBN: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
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.
Leading manufacturers include bioMerieux, Inc. and Bruker Daltonics GmbH & Co. KG.
FDA 510(k) Cleared Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Devices (Product Code QBN)
About Product Code QBN - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QBN since 2018, with 3 receiving FDA clearance (average review time: 180 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QBN have taken an average of 90 days to reach a decision - down from 210 days historically, suggesting improved FDA processing for this classification.
QBN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →