Acucy® Influenza A&B Test with the Acucy® 2 System

The Acucy Influenza A&B Test with the Acucy 2 System is a rapid chromatographic immunoassay that detects and differentiates influenza A and B viral nucleoprotein antigens from anterior nasal and nasopharyngeal swabs. It is intended as an aid in diagnosing influenza A and B infections in patients with respiratory symptoms, with results available in 15 minutes.

The Acucy 2 Reader is a new instrument platform that replaces the original Acucy Reader. Both systems use the same lateral flow cassette test format with qualitative results (positive, negative, or invalid). The Acucy 2 offers two operational modes—WALK AWAY (automatic timed development) and READ NOW (manual timing)—compared to the original Acucy's single mode. Both readers measure absorbance intensity and apply method-specific algorithms for result interpretation.

Not stated in this summary.

Substantial equivalence is established through identical analytical performance of the Acucy 2 Reader compared to the predicate Acucy Reader. Limit of detection testing across four influenza strains (A/Michigan, A/Singapore, B/Phuket, B/Colorado) on two device lots showed identical LoD values for both readers. Within-laboratory repeatability achieved 100% agreement across all sample types on both instruments. Multi-site reproducibility studies on the Acucy 2 demonstrated 98.9–100% accuracy across three sites. Method comparison of the two readers on clinical samples showed 100% positive percent agreement for Flu B and 100% for Flu A (98.3% negative percent agreement). The same assay targets, specimen types, test format, and 15-minute result time confirm functional equivalence despite the instrument upgrade.