Nano-Check Influenza+COVID-19 Dual Test

The Nano-Check Influenza+COVID-19 Dual Test is a rapid lateral flow immunoassay for qualitative detection and differentiation of influenza A and B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens. It is intended for use in patients presenting with symptoms of respiratory infection and is for prescription use only in CLIA-waived clinical settings.

The device is substantially identical to the predicate (Healgen Rapid Check COVID-19/Flu A&B Antigen Test) in all material respects: both use lateral flow immunochromatography technology, detect the same three analytes in anterior nasal swabs, provide qualitative results, require 15-minute reading time, and use visual interpretation. The only meaningful difference is that the candidate is prescription-use only and for CLIA-waived settings, whereas the predicate is over-the-counter self-testing.

Not stated in this summary. The document does not cite specific consensus standards (ISO, IEC, ASTM, etc.) for device development or validation.

Substantial equivalence is supported by: (1) identical intended use (detection of Flu A/B and SARS-CoV-2 antigens in nasal swabs from symptomatic patients), (2) identical technological platform (lateral flow immunochromatography with colloidal gold-conjugated antibodies and streptavidin capture), (3) comprehensive analytical validation showing 100% precision at higher concentrations, no cross-reactivity with 50 pathogens, no endogenous/exogenous interference, and consistent lot-to-lot performance, and (4) clinical data from 1,969 subjects demonstrating sensitivity and specificity (SARS-CoV-2: 87.6%/99.8%, Flu A: 86.9%/99.6%, Flu B: 86.8%/99.7%) that are consistent with predicate device performance and do not raise new safety or effectiveness questions.