K241915 is an FDA 510(k) clearance for the CareSuperb™ COVID-19 Antigen Home Test. This device is classified as a Over-the-counter Covid-19 Antigen Test (Class II - Special Controls, product code QYT).
Submitted by Access Bio, Inc. (Somerset, US). The FDA issued a Cleared decision on January 29, 2025, 212 days after receiving the submission on July 1, 2024.
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 | K241915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | January 29, 2025 |
| Days to Decision | 212 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. |