Nano-Check Influenza A+B Test

The Nano-Check Influenza A+B Test is a lateral flow immunochromatographic assay for qualitative detection of influenza A and B nucleoprotein antigens from anterior nasal swab samples in patients with respiratory infection symptoms. It is intended as an aid in differential diagnosis of influenza A and B viral infections and is for prescription use only.

Both the candidate device and predicate (BD Veritor System) use immunochromatographic technology to detect influenza A and B viral nucleoprotein antigens with qualitative results. Key differences are: the candidate has a 15-20 minute reading time versus the predicate's 10-15 minutes; the candidate accepts anterior nasal swabs while the predicate accepts nasal and nasopharyngeal swabs; and the candidate uses visual determination versus the predicate's opto-electronic reader.

Not stated in this summary.

The Nano-Check Influenza A+B Test is substantially equivalent to the BD Veritor predicate because both devices share the same intended use, measurand (influenza A and B nucleoprotein antigens), assay principle (immunochromatography), and regulatory classification (21 CFR 866.3328, Class II). Non-clinical performance demonstrates equivalent precision, specificity, and analytical sensitivity across multiple virus strains. Clinical validation with 1,969 subjects shows comparable performance: Flu A sensitivity 86.9% and specificity 99.6%; Flu B sensitivity 86.8% and specificity 99.7%, supporting that the device poses no new safety or effectiveness questions.