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

The iHealth Flu A&B/COVID-19 Rapid Test is a lateral flow immunoassay for qualitative detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens from anterior nasal swab samples. It is available in two versions: one for non-prescription home use (self-testing by ages 14+, or adults testing ages 2+) and one for professional use. Results are visually read within 15–30 minutes.

Both subject and predicate devices use lateral flow immunoassay technology with anterior nasal samples, internal procedural controls, qualitative visual readout, and single-use format. The subject device has a slightly longer time-to-result window (15–30 min vs. 15–20 min for the predicate) and does not use biotin-streptavidin/avidin chemistry. Both are stored at 2–30°C and detect the same three analytes (SARS-CoV-2 nucleocapsid, Flu A and B nucleoprotein).

Not stated in this summary.

The iHealth Flu A&B/COVID-19 Rapid Test is substantially equivalent to the WELLlife COVID-19/Influenza A&B predicate (K243256) because both detect the same three respiratory virus antigens using lateral flow immunoassay on anterior nasal swabs, with comparable indications for use, intended population, specimen type, and clinical performance. Non-clinical testing (precision, analytical specificity/interference, limit of detection, high-dose hook effect, inclusivity) and clinical performance data (≥86% PPA and ≥98% NPA across all three analytes) demonstrate equivalent safety and effectiveness.