SpotFire R/ST panel gets 510(k) clearance, CLIA waiver

April 2024—BioMérieux has received FDA 510(k) clearance and CLIA waiver approval for the BioFire SpotFire Respiratory/Sore Throat (R/ST) panel. The multiplex PCR test is for the detection and identification of nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab in case of a pharyngitis syndrome. Results are available in about 15 minutes on the BioFire SpotFire system.

The panel is CE marked under the in vitro diagnostic directive and has been submitted for CE marking under in vitro diagnostic regulation.

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