FDA Clears Extra 170 Species and Species Groups Added to MALDI Biotyper CA
Bruker has received 510(k) clearance from the FDA for library and methods expansion for the MALDI Biotyper CA System, sold in the United States for clinical microbiology.
In November 2013, Bruker received FDA 510(k) clearance for a first claim for the MALDI Biotyper CA System, an IVD solution, which included Bruker’s global market leading MALDI Biotyper instrumentation; software; a library of 40 aerobic Gram negative bacterial species or species groups, covering 100 clinically relevant species; in vitro diagnostic reagents; and standard operating procedures.
The recent clearance of a second, expanded claim now adds 170 species and species groups, representing 180 clinically-relevant species of aerobic Gram positive, fastidious Gram negatives, Enterobacteriaceae, anaerobic bacteria and yeasts. In addition, customers will have additional specimen preparation options to further optimize workflows.
As a result of the latest 510(k) clearance, the MALDI Biotyper CA System can now in total identify 210 species or species groups, covering 280 clinically relevant bacteria and yeast species, and representing more than 98% of the typical bacterial identification workflow of clinical microbiology laboratories.
As part of its continued, recent clinical trials, Bruker had submitted data from multi-center studies to the FDA, consisting of more than 10,000 spectra. Results generated by the MALDI Biotyper CA System were compared to 16s rRNA molecular sequencing for bacteria and ITS sequencing for yeasts. This was supplemented by protein gene sequencing, which showed that 98.9% of the isolates tested have resulted in correct identifications to the genus or species level, with only 0.9% of isolates unable to be identified. This level of performance is the highest identification accuracy for any mass spectrometry-based bacterial and yeast identification system.
Frank H. Laukien, Ph.D., President and CEO of Bruker Corporation, stated: "The MALDI Biotyper has changed the paradigm of bacterial identification worldwide due to its dramatically faster time-to-result, exceptional identification performance, ease of use, cost effectiveness and robust, compact instrumentation. The most recent 510(k) clearance for the MALDI Biotyper CA System further expands its clinical utility by offering the largest FDA-cleared library for expedited, high-accuracy identification of bacteria and yeasts. This latest clearance allows an even larger segment of US hospitals and clinical microbiology laboratories to adopt this revolutionary technology for serving their infectious disease physicians and patients, and opens the door for making it the new standard of care."
Some MALDI BioTyper CA identification results displayed are non-clinically validated organisms. These results are displayed in the MALDI Biotyper CA report in the interest of public health as a means of directing the required additional laboratory testing.
About the MALDI Biotyper Platform and the MALDI Biotyper CA System
The MALDI Biotyper platform achieves classification and identification of microorganisms reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry. The FDA cleared MALDI Biotyper CA System is offered for US clinical microbiology laboratories.
applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing, and quality control, as well as veterinary microbiology. Bruker’s robust MALDI Biotyper methods requires minimal sample preparation and offers low consumables cost per sample. Over 1,500 microbiology laboratories worldwide have selected Bruker as their supplier of MALDI-TOF systems for microbiology testing, with over 300 systems sold in the Americas to date.
The MALDI Biotyper is available in a Research Use Only (RUO) version, as well as in an IVD-CE version according to EU directive EC/98/79 in certain European countries. Currently the CE-IVD labelled IVD-MALDI Biotyper is available for clinical microbiology routine usage around the world including Europe, Canada, Argentina, Mexico, Colombia and Ecuador in the Americas and in China, Japan, Hong Kong, Singapore, Malaysia, Taiwan and Australia in Asia Pacific.
For more information visit www.maldibiotyper.com
Date Published: 7th April 2015
Source article link: Bruker Daltonics Inc
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