CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

The CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is a lateral flow immunoassay for qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B antigens from anterior nasal swab samples. It is intended for non-prescription home use by individuals aged 14 and older testing themselves, or adults testing children aged 2 and older who have signs and symptoms of respiratory tract infection.

Both devices use lateral flow immunochromatographic assay principles with identical specimen type (anterior nasal swabs), storage conditions (2-30°C), internal controls, and visual result interpretation. The proposed device uses an adaptor-based design with a cylindrical conjugate wick filter versus the predicate's standard lateral flow design, with slightly faster development time (10-15 minutes vs. 10-20 minutes). Both are Class II devices with product code SCA under regulation 21 CFR 866.3987.

Not stated in this summary.

The CareSuperb device is substantially equivalent because it shares the same fundamental lateral flow immunoassay technology, identical target analytes and specimen types, comparable analytical performance (LoDs, precision >95% agreement across lots), and clinically validated performance (92.5% PPA and 99.6% NPA for SARS-CoV-2; 85.6% and 99.0% for Influenza A; 86.0% and 99.7% for Influenza B) matching the predicate's intended use population and claims. The adaptor-based design is a minor technological variation that enhances performance without changing the fundamental detection principle or clinical application.