China FDA approves Bruker MALDI-TOF system for use as a medical device

Bruker (Beijing, China) has received clearance from the China Food and Drug Administration (CFDA; also in Beijing) to market and sell its in vitro diagnostic (IVD) MALDI Biotyper system as a medical device in China for identifying microorganisms isolated from human specimens.

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Starting from a culture, the IVD MALDI Biotyper allows for microbial identification in a few minutes without further time-consuming incubation steps. The system features the company's microflex matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometry-based identification to enable analysis of species that have been difficult to identify by previous microbiology techniques. An increasing number of case reports describe the identification of microorganisms causing human infections, which previously have been isolated only from environmental sources. The comprehensive IVD MALDI Biotyper reference library now covers more than 2300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes and yeasts, and often enables the identifications of unexpected microorganisms.

"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," says Dr. Lisong Shen, the Director of Laboratory Medicine at Xin Hua Hospital affiliated with Shanghai Jiao Tong University School of Medicine and president of the Shanghai Society of Laboratory Medicine. "With the significant reduction of the time to result for identification of pathogenic bacteria, the patient outcomes will improve and the cost of care will be reduced significantly."

Fast species ID is an important component to improve antibiotic stewardship by helping to guide selection of the right therapeutic drug(s). This is getting more and more important because of the increasing threat by multiresistant bacteria causing severe infections. In 2009, the IVD MALDI Biotyper received the CE mark according to the European IVD directive EC/98/79. Now, the system is available in most of Europe; in the Americas in Canada, Argentina, Colombia, Ecuador, and Mexico; and in the Asia/Pacific region in Japan, China, Hong Kong, Singapore, Taiwan, and Australia. In November 2013, the MALDI Biotyper CA System received clearance for a first claim by the U.S. FDA.

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