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Medical Devices / Regulatory Affairs / Submissions and Approvals

Bruker Gets 510(k) OK for MALDI Biotyper

Dec. 2, 2013

The FDA has granted 510(k) clearance for Bruker’s MALDI Biotyper CA system for the identification of Gram negative bacteria from human samples using proteomic fingerprinting. The company plans launch the device in hospitals and reference laboratories in the first quarter of 2014.

The MALDI Biotyper, which is small enough to fit on a bench top, consists of several parts: the MALDI-TOF mass spectrometer, software, reagents with in vitro diagnostic labels and a reference library of microorganism spectra.

Results from a multisite clinical trial comparing the MALDI Biotyper CA system with 16S ribosomal gene sequencing showed the two to be comparable. Bruker spokesman George Goedesky emphasized that the device offers greater accuracy than similar systems, as well as faster time-to-results and lower costs.

Bruker’s MALDI Biotyper system gained CE Mark approval in the EU in 2009. Since then, the Billerica, Mass.-based devicemaker has expanded the Biotyper brand to Canada, Mexico, Argentina, Ecuador, Colombia, Japan, Malaysia, Singapore, Hong Kong and Taiwan. — Lena Freund

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