Heal-Check Rapid COVID-19 Antigen Self-Test

The Heal-Check Rapid COVID-19 Antigen Self-Test is a visually read lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens. It is intended for over-the-counter use by individuals aged 14 and older testing themselves, or adults testing individuals aged 2 and older with signs and symptoms of COVID-19.

Both the proposed device and predicate device (OHC COVID-19 Antigen Self Test K241313) are lateral flow immunoassays with no instrumentation or mobile application requirements. Both use test cassettes with internal controls, provide visual interpretation of results (positive, negative, or invalid), and detect SARS-CoV-2 nucleocapsid protein from lay user-collected anterior nasal swabs in 15–30 minutes.

Not stated in this summary.

The proposed device has identical intended use, technological platform, and assay principle as the predicate device. Clinical data from 1,380 symptomatic subjects showed 86.7% positive percent agreement and 99.8% negative percent agreement with FDA-cleared RT-PCR comparators. Analytical studies confirmed sensitivity (multiple SARS-CoV-2 variants detected), specificity (no cross-reactivity or microbial interference), precision, and robustness comparable to the predicate, with the same age population and OTC use conditions.