BioMĂ©rieux gets FDA 510(k) clearance, CLIA waiver approval for panel

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BioMĂ©rieux announced today that its Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel has received dual U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.

The panel is a multiplex polymerase chain reaction test designed to detect and identify nucleic acids from 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections, with results in about 15 minutes. Samples can be taken using either a nasopharyngeal or throat swab depending on the whether the suspected infection is respiratory or associated with pharyngitis.

The Biofire Spotfire R/ST Panel is the third panel designed for use on the Biofire Spotfire system to receive FDA clearance; the other two are the Biofire Spotfire Respiratory Panel and Biofire Spotfire Respiratory Panel Mini, which detect 15 and five of the most common respiratory pathogens, respectively.

The CLIA waiver means that the Biofire Spotfire system and the authorized panels may be used by non-lab professionals and in any clinical setting at the point of care, including clinics, doctors' offices, pharmacies, and emergency departments.

 BioMĂ©rieux also plans to submit its Biofire Spotfire R/ST Panel Mini to the FDA for review for 510(k) clearance; the R/ST Panel Mini, which is not yet available for sale, detects and identifies nucleic acids from five common viral and bacterial pathogens from a nasopharyngeal or throat swab. 

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