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Bruker Receives China FDA Clearance for IVD MALDI Biotyper

NEW YORK (GenomeWeb) – Bruker said today that it has received clearance from the China Food and Drug Administration to sell its IVD MALDI Biotyper as a medical device for the identification of microorganisms isolated from human specimens.

According to Bruker, the device can identify more than 2,300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes, and yeasts.

"The importance of MALDI-TOF mass spectrometry technology in the clinical microbiology field is widely recognized in mainland China now," Lisong Shen, director of laboratory medicine at Shanghai's Xin Hua Hospital, said in a statement. "The approval of Bruker's IVD MALDI Biotyper system will further promote the development of clinical microbiology science in the country, not only in laboratory medicine, but also for infection control work within the hospitals."

Bruker received US FDA 510(k) clearance for the device in November 2013 and an EU CE mark in 2009.

The Biotyper platform identifies microbes by matching the protein profiles of sample organisms generated via MALDI mass spec to profiles contained in a proprietary database. According to Bruker, the system offers significant improvements in speed, price, and accuracy compared to conventional biochemical methods.