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 Wondfo USA Co., Ltd., ACON Laboratories, Inc. and Ihealth Labs, Inc..
FDA 510(k) Cleared Multi-analyte Respiratory Virus Antigen Detection Test Devices (Product Code SCA)
About Product Code SCA - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code SCA since 2024, with 10 receiving FDA clearance (average review time: 145 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SCA devices are reviewed by the Microbiology panel. Browse all Microbiology devices →