FINDER Flu A&B/SARS-CoV-2 Test

The FINDER Flu A&B/SARS-CoV-2 Test is an automated, multiplexed, real-time RT-PCR test that simultaneously detects and differentiates SARS-CoV-2, influenza A, and influenza B viral nucleic acid in nasopharyngeal swab specimens from individuals with respiratory tract infection symptoms. Results are intended as an aid in differential diagnosis used alongside clinical and epidemiological information, with testing completed in approximately 20 minutes.

The subject device uses electrowetting-based digital microfluidics on a single-use cartridge with magnetic-bead based solid-phase extraction for sample preparation, compared to the predicate's extraction-free chemistry. Both are real-time RT-PCR assays with qualitative results on automated platforms; the FINDER achieves results in ~20 minutes versus the predicate's ~90 minutes. The FINDER uses the FINDER Instrument while the predicate uses the LIAISON MDX.

Not stated in this summary.

The FINDER Flu A&B/SARS-CoV-2 Test is substantially equivalent to the predicate DiaSorin Simplexa COVID-19 & Flu A/B Direct (K220963) because both share identical product codes (QOF), regulations (21 CFR 866.3981), intended use (simultaneous detection and differentiation of the same three pathogens in nasopharyngeal swabs for differential diagnosis), specimen types, target pathogens, qualitative detection methodology, and automated sample processing. Comprehensive analytical studies (sensitivity, specificity, precision, reproducibility) and clinical performance data (PPA 95.4–97.6%, NPA 97.2–99.8%) demonstrate equivalent performance despite technology differences.