K251753 is an FDA 510(k) clearance for the GenaCheck COVID-19 Rapid Self-Test. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3984. For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older..
| 510(k) Number | K251753 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |