Originally Published IVD Technology January/February 2004
INDUSTRY NEWS
NotableIn response to a petition submitted by Panbio (Windsor, Brisbane, Australia) FDA has classified the company's West Nile virus IgM capture ELISA as Class II (special controls) under the generic name "West Nile virus, Serological Reagents." West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti–West Nile virus IgM antibodies in human serum from individuals who have signs and symptoms consistent with viral meningitis or encephalitis caused by West Nile virus. The serological test is intended for use in conjunction with other clinical or laboratory tests.
The Class II special controls guidance provides information on how to meet 510(k) submission requirements for the device and includes recommendations for labeling and performance studies. The guidance can be accessed via the Internet at www.fda.gov/cdrh/oivd/guidance/1206.html.
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