DeviceClearance

Product code QBN— Microbiology

MALDI Biotyper CA System

Classification name
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Device class
Class 2
Regulation
21 CFR 866.3378
Advisory panel
Microbiology
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QBN under 21 CFR 866.3378, via openFDA

Market context for product code QBN

FDA has cleared 4 devices under product code QBN between 2018 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBN

Recent clearances under product code QBN

Data sourced from openFDA. This site is unofficial and independent of the FDA.