Cleared Traditional

GenaCheck COVID-19 Rapid Self-Test

K251753 · Genabio Diagnostics, Inc. · Microbiology

Sep 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K251753 is an FDA 510(k) clearance for the GenaCheck COVID-19 Rapid Self-Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Genabio Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on September 5, 2025, 88 days after receiving the submission on June 9, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K251753 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2025
Decision Date	September 05, 2025
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.