WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

The WELLlife Flu A&B Home Test and WELLlife Influenza A&B Test are lateral flow immunochromatographic assays for qualitative detection and differentiation of influenza A and B nucleoprotein antigens from anterior nasal swab samples. The OTC version is intended for self-testing by individuals aged 14+ or adults testing others aged 2+; the professional version is for similar use in clinical settings. Negative results are presumptive and should be confirmed by FDA-cleared molecular assay; positive results do not rule out co-infections.

Both candidate and predicate devices use identical lateral flow immunochromatographic technology with anterior nasal swab sampling, qualitative visual results readable in 10 minutes, and internal procedural controls. The key difference is that the predicate detects three analytes (Flu A, Flu B, and SARS-CoV-2), while the candidate detects only Flu A and Flu B nucleoprotein antigens, representing a removal of the COVID-19 detection capability.

Not stated in this summary.

The candidate device is substantially equivalent because it shares the same intended use (detection of influenza A and B in symptomatic patients from nasal swabs), identical test principle and format (lateral flow immunochromatography), equivalent performance characteristics (10-minute turnaround, visual readout), and comparable analytical and clinical performance to the predicate. Although the candidate removes SARS-CoV-2 detection, the retained Flu A and B detection performance is supported by non-clinical data (precision, sensitivity, specificity with no cross-reactivity) and clinical data showing 92.4% positive percent agreement and 100% negative percent agreement for Flu A, and 91.4% and 100% for Flu B against an FDA-cleared molecular comparator.