Clungene RSV Antigen Rapid Test

The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay for qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. It is intended for in vitro diagnostic use as an aid in diagnosing RSV infections. Negative results do not preclude RSV infection and should be confirmed by viral cell culture or an FDA-cleared molecular assay.

Both the Clungene RSV Antigen Rapid Test and predicate device (Nano-Check RSV Test, K240280) use immunochromatographic/lateral flow technology with a cassette format, qualitative result interpretation, and no instrumentation required. The main difference is specimen type: the candidate uses nasopharyngeal swabs while the predicate uses anterior nasal swabs. Both target RSV nucleoprotein antigen.

Not stated in this summary.

The Clungene RSV Antigen Rapid Test is substantially equivalent to the predicate device because both share the same regulatory classification (Class II), product code (GQG), CFR regulation (21 CFR 866.3480), intended use (qualitative RSV antigen detection with similar clinical disclaimers), technology (immunochromatographic assay), and result interpretation method. Analytical and clinical performance data demonstrate adequate sensitivity (88.3% PPA) and specificity (99.2% NPA) compared to FDA-cleared RT-PCR, with no cross-reactivity, microbial interference, or hook effects observed.