bioMérieux receives U.S. FDA Special 510(k) clearance and CLIA-waiver for its BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
bioMérieux announced that its BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).
For use on the BIOFIRE SPOTFIRE system, the BIOFIRE SPOTFIRE R/ST Panel Mini is a unique multiplex PCR test that detects 5 of the most common viral and bacterial causes of respiratory or sore throat infections in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected.
The BIOFIRE SPOTFIRE system is a unique POC platform providing fast results and offering flexibility with the capability of running either a large multiplex respiratory test with up to 15 pathogens with the BIOFIRE SPOTFIRE R/ST Panel, already FDA-cleared and CLIA-waived, or a small multiplex respiratory test with 5 pathogens with the BIOFIRE SPOTFIRE R/ST Panel Mini.
