Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

Bruker MALDI Biotyper™ Receives CFDA Clearance

Published: Thursday, June 26, 2014
Last Updated: Monday, June 30, 2014
Bookmark and Share
Company receives clearance from the China Food and Drug Administration to market and sell its IVD MALDI Biotyper System as a medical device in China for the identification of microorganisms isolated from human specimens.

MALDI Biotyper-based microbial identification has major advantages compared to classical automated biochemical testing, including faster time to result (TTR) and better information with deeper and broader species coverage. Starting from a culture, the IVD MALDI Biotyper allows for microbial identification in a few minutes without further time-consuming incubation steps.  With this paradigm shift in clinical practice, microbial identification is typically available one day earlier than with biochemical techniques. Additionally, MALDI-TOF mass spectrometry-based identification does not have the limitations of biochemical testing and can analyze 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 Biotyperreference library now covers more than 2,300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes and yeasts, and often enables the identifications of unexpected microorganisms.

The IVD MALDI Biotyper System includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, automated analysis software, the IVD Bacterial Test Standard (BTS), a 96-spot MALDI target and an extensive library of microorganism reference entries. The microflex is the market-leading MALDI-TOF mass spectrometer for microbiology with a number of unique features specifically designed for applications in routine laboratories:

• State-of-the-art benchtop system to save lab space      
• Fiber optics laser coupling for optimized robustness after preventive maintenance or service  
• Self-cleaning ion source for optimized robustness in high-throughput applications      
• Oil-free membrane pump for quiet operation in routine laboratories •        
• Rapid exchange of target plates to reduce delays between measurement runs    
• Smart Spectra Acquisition™ saves laser life-time and increases speed of analysis 

Commenting on the CFDA clearance, 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, congratulated: “The importance of MALDI-TOF mass spectrometry technology in the clinical microbiology field is widely recognized in mainland China now. 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. 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.”   

Dr. Lu Xinxin, the Director of the Clinical Laboratory Department at the Capital Medical University-Affiliated Beijing Tongren Hospital, added: “MALDI-TOF MS is a revolutionary technology in microbiology. It is rapid, easy to operate and enjoyable to navigate in the microbial world."

Dr. Wolfgang Pusch, Executive Vice President of the Microbiology Business at Bruker Daltonics, pointed out: “The regulatory approval of the IVD MALDI Biotyper System in China is a major milestone and an additional achievement in our regulatory strategy to support the further growth of our business.  We are committed to fully support our growing customer base in China. After the regulatory approval, we have immediately received positive feedback and have seen strong demand for the IVD MALDI Biotyper from the Chinese clinical microbiology market.”

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 multi-resistant bacteria causing severe infections. The IVD MALDI Biotyper System combines the most advanced MALDI-TOF mass spectrometer with the most extensive microbial species library in the market. Bruker continuously invests in bringing the MALDI Biotyper into clinical routine laboratories. In 2009 the IVD MALDI Biotyper received the CE-mark according to the European IVD directive EC/98/79. Since then Bruker has continuously expanded the species coverage of the system and the geographic coverage of regulatory clearance, thereby adding clinical value for the existing customer base, as well as expanding access by new customers in additional countries. The IVD MALDI Biotyper is now 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 additional, in November 2013 the MALDI Biotyper CA System received clearance for a first claim by the US FDA. 

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More Than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Bruker’s NMR FoodScreener™ Laboratory Achieves ISO/IEC 17025 Accreditation
Bruker announced that its NMR FoodScreener™ laboratory for food authenticity and quality determination, located in Rheinstetten, Germany, has been granted ISO/IEC 17025 accreditation.
Monday, September 28, 2015
Full Range of Bruker Systems Installed in New Pre-Clinical Imaging Laboratory
Researchers, clinicians, health educators and policy makers all gathered as the new Multidisciplinary Centre for Research into Obesity and Related Comorbidities (Cepid-OCRC) was opened at da Universidade Estadual de Campinas (UNICAMP).
Thursday, June 18, 2015
UK National Graphene Institute Selects Bruker as Official Partner
World-leading graphene research facility purchases multiple Bruker AFMs.
Tuesday, April 07, 2015
PREMIER Biosoft Announces Reseller Agreement with Bruker
Agreement aims to advance lipidomics and metabolomics research.
Monday, November 17, 2014
Bruker Sells GC Business
Bruker completed the divestiture of its GC and GC single-quadrupole (GC-SQ) mass spectrometry products to Techcomp Europe Ltd on October 31st.
Tuesday, November 04, 2014
Bruker Awarded Fourth PeakForce Tapping Patent
AFM mode uniquely combines highest resolution imaging and material property mapping.
Thursday, July 24, 2014
Using LC-MS to Analyse Sulfonamides in Food Grade Honey
Sulfonamides are one of a number of groups of chemicals whose presence in honey is limited by international regulations.
Tuesday, July 22, 2014
Bruker Reports 7% Revenue Growth in Q4
Bruker Corporation reported financial results for its fourth quarter and full year ended December 31, 2013.
Wednesday, February 19, 2014
Bruker Opens New Preclinical Imaging Center of Excellence for the Americas
Massachusetts Center will provide advanced development, demonstration and customer support capabilities for Bracer’s unique multimodal preclinical imaging systems portfolio.
Thursday, January 30, 2014
Bruker Corporation Appoints Dr. Gilles Martin to its Board of Directors
Dr. Martin is Chairman and Chief Executive Officer of the Eurofins Scientific Group.
Monday, January 20, 2014
World’s First Compact 900 MHz Actively Refrigerated Magnet for NMR Installed at UCSD
Bruker announce the successful installation of an Ascend™ Aeon 900 magnet, the world’s first compact, single-story NMR magnet with active refrigeration.
Wednesday, December 11, 2013
Bruker Granted FDA Clearance to Market the MALDI Biotyper CA System
Bruker able to market MALDI Biotyper CA System in the US for the identification of Gram negative bacterial colonies cultured from human specimens.
Tuesday, November 26, 2013
Bruker and SISCAPA Assay Technologies Announce Second-Phase Collaboration Agreement
The ongoing collaboration aims to exploit MALDI-TOF instruments as an alternative to nano-LC-MS technology currently used in many SISCAPA assays.
Monday, September 16, 2013
Bruker Announces Acquisition of Prairie Technologies
Acquisition strengthens Bruker Nano Surfaces Division's position in life science markets.
Friday, September 13, 2013
Novel Approach for Inborn Errors of Metabolism Screening by NMR
Clinical IEM-by-NMR screening study in Turkey measures 65 metabolites in urine simultaneously, including 20 endogeneous metabolites and 45 metabolites associated with inborn errors of metabolism.
Wednesday, September 04, 2013
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
How a Genetic Locus Protects Adult Blood-Forming Stem Cells
Mammalian imprinted Gtl2 protects adult hematopoietic stem cells by restricting metabolic activity in the cells' mitochondria.
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
New Tech Vastly Improves CRISPR/Cas9 Accuracy
A new CRISPR/Cas9 technology developed by scientists at UMass Medical School is precise enough to surgically edit DNA at nearly any genomic location, while avoiding potentially harmful off-target changes typically seen in standard CRISPR gene editing techniques.
The MaxSignal Colistin ELISA Test Kit from Bioo Scientific
Kit can help prevent the antibiotic apocalypse by keeping last resort drugs out of the food supply.
"Good" Mozzie Virus Might Hold Key to Fighting Human Disease
Australian scientists have discovered a new virus carried by one of the country’s most common pest mosquitoes.
Non-Disease Proteins Kill Brain Cells
Scientists at the forefront of cutting-edge research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s have shown that the mere presence of protein aggregates may be as important as their form and identity in inducing cell death in brain tissue.
Closing the Loop on an HIV Escape Mechanism
Research team finds that protein motions regulate virus infectivity.
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Potential Treatment for Life-Threatening Viral Infections Revealed
The findings point to new therapies for Dengue, West Nile and Ebola.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos