CareSuperb™ COVID-19 Antigen Home Test

The CareSuperb COVID-19 Antigen Home Test is a lateral flow immunoassay device for rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. It is designed for over-the-counter, self-testing use by individuals aged 14 and older (or adults testing children aged 2 and older) with signs and symptoms of COVID-19, with results available in 15-30 minutes via visual interpretation.

Both the subject device and predicate device use identical lateral flow immunoassay technology targeting SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swabs. The subject device uses ~250 µL extraction buffer volume versus the predicate's 4 drops, and includes a sample port design feature. Both are Class II, qualitative, visually-read tests with identical intended use settings, storage conditions (2-30°C), and development time.

Not stated in this summary.

Substantial equivalence is supported by: (1) identical test principle, analyte target, specimen type, and intended use population/setting; (2) equivalent clinical performance with 97.2% positive percent agreement and 98.8% negative percent agreement in 646 symptomatic subjects against FDA-cleared molecular comparator; (3) robust analytical performance across precision, limit of detection, cross-reactivity, interfering substances, and inclusivity studies covering multiple SARS-CoV-2 variants; (4) successful usability and readability studies demonstrating lay users can perform the test correctly with provided instructions; and (5) equivalent performance to predicate device Flowflex COVID-19 Antigen Home Test (K230828).