iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

The iHealth Flu A&B/COVID-19/RSV Rapid Test is a lateral flow immunoassay for rapid detection and differentiation of influenza A, influenza B, SARS-CoV-2, and RSV antigens from anterior nasal swab samples. It is available in two versions: one for non-prescription home use by individuals aged ≥14 years (or adults testing individuals ≥6 months), and one for professional use. Results are obtained in 15–30 minutes.

The candidate device detects four analytes (Flu A/B, SARS-CoV-2, RSV) versus the predicate's three (Flu A/B, SARS-CoV-2). Both use lateral flow immunoassay technology with internal procedural controls, visually read results, anterior nasal swabs, and qualitative detection. The candidate has a slightly longer detection window (within 6 days versus 4 days of symptom onset) and broader age range for testing.

Not stated in this summary.

The candidate device is substantially equivalent to the predicate (WELLlife COVID-19/Influenza A&B, K243256) because both share the same product code (SCA), regulation (21 CFR 866.3987), class (II), platform (lateral flow immunoassay), specimen type (anterior nasal), and intended users (OTC and professional). The addition of RSV detection and slight modifications to clinical parameters do not alter the fundamental technological approach or safety/effectiveness profile, supported by comparable analytical and clinical performance data.