FDA Product Code SCA: Multi-analyte Respiratory Virus Antigen Detection Test
Rapid antigen testing for multiple respiratory viruses simultaneously reduces the need for sequential single-pathogen tests. FDA product code SCA covers multi-analyte respiratory virus antigen detection systems.
These lateral flow or microfluidic assays simultaneously detect antigens from multiple respiratory pathogens — including influenza A/B, RSV, and SARS-CoV-2 — from a single nasal or nasopharyngeal swab, delivering results within 15-30 minutes without laboratory equipment.
SCA devices are Class II medical devices, regulated under 21 CFR 866.3987 and reviewed by the FDA Microbiology panel.
Leading manufacturers include ACON Laboratories, Inc. and Princeton BioMeditech Corp..
List of Multi-analyte Respiratory Virus Antigen Detection Test devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Multi-analyte Respiratory Virus Antigen Detection Test devices (product code SCA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →