Devices

FDA Clears Cepheid Xpert Carba-R Test

FDA has cleared a Cepheid 510(k) for the Xpert Carba-R, an in vitro diagnostic test for identifying distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP. “The emergence of carbapenemase producing organisms, known as CPOs, represents a significant global healthcare risk since these bacteria are resistant to many of the beta-lactam antibiotics used for empiric therapy for gram negative infections,” the company says. “These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality.” The molecular test uses a bacterial isolate to deliver a result in under an hour. The Xpert Carba-R is the 20th IVD test available to run on Cepheid’s GeneXpert System.

FDA Clears Cepheid Xpert Carba-R Test

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