QYT · Class II · 21 CFR 866.3984

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..

14
Total
14
Cleared
177d
Avg days
2023
Since
Growing category - 9 submissions in the last 2 years vs 5 in the prior period
Consistent review times: 166d avg (recent)

FDA 510(k) Cleared Over-the-counter Covid-19 Antigen Test Devices (Product Code QYT)

14 devices
1–14 of 14
Cleared Jun 05, 2026
Fastep COVID-19 Antigen Pen Home Test
K260754
Assure Tech., LLC
Microbiology · 88d
Cleared Apr 13, 2026
Heal-Check Rapid COVID-19 Antigen Self-Test
K260095
Healgen Scientific, LLC
Microbiology · 90d
Cleared Mar 13, 2026
GenBody COVID-19 Ag Home Test
K251916
Genbody.Inc.
Microbiology · 263d
Cleared Oct 12, 2025
COVID-19 Detect Rapid Self -Test
K251595
InBios International, Inc.
Microbiology · 138d
Cleared Sep 05, 2025
GenaCheck COVID-19 Rapid Self-Test
K251753
Genabio Diagnostics, Inc.
Microbiology · 88d
Cleared May 30, 2025
OHC COVID-19 Antigen Self Test
K241313
Osang, LLC
Microbiology · 386d
Cleared Feb 11, 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518
Abbott Diagnostics Scarborough, Inc.
Microbiology · 90d
Cleared Jan 29, 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915
Access Bio, Inc.
Microbiology · 212d
Cleared Sep 30, 2024
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
K241317
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 143d
Cleared Jun 21, 2024
CorDx Tyfast COVID-19 Ag Rapid Test
K240728
CorDx, Inc.
Microbiology · 95d
Cleared May 31, 2024
iHealth COVID-19 Antigen Rapid Test
K233842
Ihealth Labs, Inc.
Microbiology · 179d
Cleared Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
K233373
ACON Laboratories, Inc.
Microbiology · 200d
Cleared Mar 22, 2024
QuickVue COVID-19 Test
K231795
Quidel Corporation
Microbiology · 276d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828
ACON Laboratories, Inc.
Microbiology · 227d

About Product Code QYT - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code QYT since 2023, with 14 receiving FDA clearance (average review time: 177 days).

Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QYT Product Code

FDA review times for QYT submissions have been consistent, averaging 166 days recently vs 195 days historically.

QYT devices are reviewed by the Microbiology panel. Browse all Microbiology devices →