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Idaho seeks FDA 510(k) clearance for expanded FilmArray RP

Idaho Technology is seeking the US Food and Drug Administration's (FDA) 510 (k) market clearance for its expanded FilmArray Respiratory Panel (RP), a user-friendly Multiplex PCR assay.

The expanded FilmArray Respiratory Panel includes the addition of five more respiratory pathogens to its already existing FDA cleared 15 respiratory pathogens.

The five new respiratory pathogens include Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43.

Idaho Technology CEO Kirk Ririe said they have been quite pleased with how well the FilmArray system has been received by the clinical laboratory community and by how quickly it is being adopted.

"Many of our potential and current hospital laboratory customers are eagerly anticipating the launch of the expanded FilmArray Respiratory Panel," Ririe said.

The company is currently developing additional applications for its FilmArray system including a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel.

The company said it is planning to start clinical testing its blood culture ID panel later in 2012.