FDA Product Code QYT: Over-the-counter Covid-19 Antigen Test
Home COVID-19 testing enables immediate self-diagnosis without laboratory infrastructure. FDA product code QYT covers over-the-counter COVID-19 antigen tests for consumer use.
These lateral flow antigen tests provide a rapid visual result for the presence of SARS-CoV-2 antigen in a nasal swab sample within 15 minutes. They are cleared for repeated use by symptomatic and asymptomatic individuals without a healthcare professional.
QYT devices are Class II medical devices, regulated under 21 CFR 866.3984 and reviewed by the FDA Microbiology panel.
Leading manufacturers include ACON Laboratories, Inc., Quidel Corporation and Ihealth Labs, Inc..
FDA 510(k) Cleared Over-the-counter Covid-19 Antigen Test Devices (Product Code QYT)
About Product Code QYT - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code QYT since 2023, with 13 receiving FDA clearance (average review time: 184 days).
Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QYT have taken an average of 168 days to reach a decision - down from 234 days historically, suggesting improved FDA processing for this classification.
QYT devices are reviewed by the Microbiology panel. Browse all Microbiology devices →