BD Veritor System for SARS-CoV-2

The BD Veritor System for SARS-CoV-2 is a rapid (15-minute) chromatographic digital immunoassay that detects SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens from symptomatic patients. It is intended as an aid in COVID-19 diagnosis, used either with repeat testing over three days or as a single negative test followed by molecular confirmation.

Both the subject device and predicate (Nano-Check COVID-19 Antigen Test) use lateral flow immunochromatography, the same specimen type (direct anterior nasal swab), target the same analyte (SARS-CoV-2 nucleocapsid protein), have identical test time (~15 minutes), and are prescription-use devices for symptomatic populations. The key difference is result interpretation: the subject device uses the BD Veritor Plus Analyzer (instrument-read with reflectance signal subtraction), whereas the predicate relies on visual interpretation by the user.

CLSI EP05-A3:2019 (precision evaluation), CLSI EP25 (reagent stability), IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 62366-1 (usability engineering), ISO 15223-1 (symbols and labeling), and ISO 20417 (manufacturer-supplied information).

The subject and predicate devices are substantially equivalent because they share the same intended use, specimen type, analyte, assay principle, and test duration across the same patient population. The difference in result interpretation method—automated instrument reading versus visual reading—does not raise new safety or effectiveness questions, as both methods detect the same immunochromatographic signal; the analyzer simply performs objective, quantitative reflectance measurement with background subtraction instead of relying on visual line detection. Clinical data demonstrated 84.0% positive and 99.7% negative percent agreement against RT-PCR across 1,032 samples, supporting analytical performance comparable to the predicate.