BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini is an automated multiplexed PCR test that simultaneously detects and identifies respiratory viral and bacterial nucleic acids from nasopharyngeal swabs (NPS), anterior nasal swabs (ANS), or throat swabs (TS). It identifies five respiratory viruses (including SARS-CoV-2) and four additional viruses plus group A Streptococcus in throat specimens, with results available in approximately 15 minutes.

The device uses highly multiplexed nested nucleic acid amplification with melt-curve analysis, performed in two stages: a large-volume reverse transcription PCR followed by singleplex PCR in array wells with fluorescent DNA-binding dye detection. The core technology, instrumentation (BIOFIRE SPOTFIRE System), reagent storage, automated interpretation, and time-to-result remain identical to the predicate. The only change is the addition of anterior nasal swabs as a new sample type for the Respiratory Menu.

Not stated in this summary.

The submission demonstrates substantial equivalence by showing that ANS specimens perform equivalently to the predicate device's NPS specimens across all analytes. Clinical performance data from 797 ANS specimens achieved positive percent agreement of 94.3–100% and negative percent agreement of 95.0–100% compared to an FDA-cleared comparator panel, matching or exceeding the predicate's established performance thresholds. Analytical specificity and interference testing confirm no cross-reactivity or interference issues with the new sample type. Since the fundamental technology, instrumentation, reagents, and interpretation methodology are unchanged and only the specimen type is expanded with demonstrated equivalent performance, the device meets the substantial equivalence standard.