WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest

The WELLlife COVID-19 / Influenza A&B Home Test is a lateral flow immunochromatographic assay that qualitatively detects and differentiates SARS-CoV-2 nucleocapsid antigen and influenza A and B nucleoprotein antigens directly from anterior nasal swab samples. It is intended for over-the-counter home use by individuals 14 and older testing themselves, or adults testing children 2 and older, within four days of respiratory symptom onset.

The device uses the same lateral flow immunoassay principle, detects identical analytes (SARS-CoV-2, Flu A, Flu B), employs anterior nasal swab specimens, produces qualitative visual results with an internal control, and stores at 2–30°C. The only difference is result time: the candidate device reads in 10–20 minutes versus the predicate's 15–20 minutes.

Not stated in this summary.

The candidate device is substantially equivalent because it shares identical intended use, regulatory classification, disease population, user type (OTC lay users), test principle, sample type, assay targets, result mode, and control mechanism with the predicate Healgen device. Non-clinical studies demonstrate equivalent or superior analytical performance: lot-to-lot precision at 100% agreement across negative and high-concentration positive samples, inclusivity across multiple viral strains (10–100% detection), no cross-reactivity or microbial interference, and clinical study data showing 87.8% PPA and 99.8% NPA for SARS-CoV-2, 87.2% and 99.7% for Flu A, and 87.9% and 99.7% for Flu B. The minor 5-minute reduction in time-to-result represents a technological refinement that does not affect safety or effectiveness.