The clearance is for Quidel’s non-instrumented molecular diagnostic test: the AmpliVue C. difficile Assay. It is designed for the detection of toxigenic C. difficile bacterial DNA.
The company says detection of the pathogen is achieved using a hand-held, fully contained cassette that combines isothermal Helicase Dependent Amplification with its lateral flow detection technology.
“We are very pleased to receive 510(k) clearance for the first hand-held molecular device for C. difficile,” said Douglas Bryant, president and CEO of Quidel Corp. in the release. “The AmpliVue C. difficile Assay will allow hospitals currently using traditional detection methods to employ a more sensitive, rapid molecular test, thereby providing laboratory technicians and the physicians they serve with accurate, timely, and reliable diagnosis of C. difficile infections.”
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