FDA Clearance for Applied Biosystems Real-time PCR Flu Test
Applied Biosystems Inc. has received 510(k) clearance from the FDA for its new 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and Prevention. While both products received independent FDA 510(k) clearances, they are required to be used together as a system for the detection of influenza.
Together with the 7500 Fast Dx Real-Time PCR Instrument, the new CDC diagnostic assay is designed to help standardize influenza virus testing and sub-typing and provide accuracy, specificity and dependability of influenza test results among qualified laboratories that conduct influenza subtype testing in the United States. Developed through a coordinated effort between the CDC and Applied Biosystems, the new test can accurately detect and identify commonly circulating human influenza viruses as well as avian influenza A (H5N1, Asian lineage) viruses within four hours and in multiple samples at one time. The test enables clinical researchers to discriminate between both the common seasonal subtypes of flu as well as the avian influenza A subtype, in order to aid public health officials in making a rapid and accurate diagnosis.
'The FDA´s decision to clear our real-time PCR instrumentation is an important milestone for Applied Biosystems as it presents us with an exciting opportunity to apply our technology to the rapidly growing clinical diagnostics market,' said Mark Stevenson, president and chief operating officer for Applied Biosystems. 'In this instance, we´ve been able to apply our real-time PCR technology to support laboratories on the front line of influenza testing in the United States. This is an important diagnostic tool that will enhance monitoring of influenza infections each year and improve early detection of influenza viruses with pandemic potential in the United States and abroad.'
The 510(k) clearance for the 7500 Fast Dx Real-Time PCR Instrument follows the recent ISO 13485:2003 Quality System certification for the Applied Biosystems Singapore facility awarded by The British Standards Institution Americas, Inc., which enables CE Marking to the In-Vitro Diagnostics Directive 98/79/EC of products for sale within the European Community.
The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument employs 96-well format reaction plates and enables scientists to complete real-time PCR amplification in less than 40 minutes. CDC-qualified laboratories that previously purchased the 7500 Fast Real-Time PCR System should contact their Applied Biosystems representative for information on how to purchase a Dx´ upgrade to the 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC flu assay. For more information please visit:
Source: Applied Biosystems View latest company information
Posted: October 7, 2008
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