OHC COVID-19 Antigen Self Test

The OHC COVID-19 Antigen Self Test is a lateral flow immunoassay for rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from anterior nasal swab specimens. It is an over-the-counter home use test for individuals aged 14 and older testing themselves, or adults testing individuals aged 2 and older with COVID-19 symptoms within 6 days of symptom onset. Results are visually read as positive, negative, or invalid within 15 minutes.

Both the proposed device and predicate (Flowflex K230828) are lateral flow immunoassays detecting SARS-CoV-2 nucleocapsid protein from lay-user-collected anterior nasal swabs with internal controls and visual interpretation. The proposed device demonstrates a 15-minute time to result compared to the predicate's 15–30 minutes. Both are qualitative, non-instrumented tests requiring no mobile applications or complex procedures, and both are formatted as test cassettes for over-the-counter use.

Not stated in this summary. The document references standard virological and microbiological testing methodologies (TCID50/mL quantification, IU measurements using NIBSC standard 21/368) but does not cite specific consensus standards such as ISO, IEC, or ASTM.

The substantial equivalence argument rests on identical intended use (OTC SARS-CoV-2 detection from nasal swabs in symptomatic individuals) and identical technological platform (lateral flow immunoassay). Performance testing demonstrates the proposed device achieves 85.3% positive percent agreement and 99.3% negative percent agreement against molecular comparators in a 709-subject clinical study, with analytical reactivity across 9 SARS-CoV-2 variants including Omicron, and no clinically significant cross-reactivity or microbial interference. The device's analytical sensitivity (LoD 2.51 × 10³ TCID₅₀/mL), precision across lots and operators, and robustness under user-error conditions (flex studies) support that it performs comparably to the predicate without raising new safety or effectiveness concerns.