K243256 is an FDA 510(k) clearance for the WELLlife™ COVID-19 / Influenza A&B Home Test. This device is classified as a Multi-analyte Respiratory Virus Antigen Detection Test (Class II - Special Controls, product code SCA).
Submitted by Wondfo USA Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on January 16, 2025, 93 days after receiving the submission on October 15, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3987. A Multi-analyte Respiratory Virus Antigen Detection Test Is An In Vitro Diagnostic Device Intended For The Detection And/or Differentiation Of Respiratory Viruses Directly From Respiratory Clinical Specimens. The Device Is Intended To Be Performed At The Site Of Sample Collection, Does Not Involve Sample Storage And/or Transport..
| 510(k) Number | K243256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SCA - Multi-analyte Respiratory Virus Antigen Detection Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3987 |
| Definition | A Multi-analyte Respiratory Virus Antigen Detection Test Is An In Vitro Diagnostic Device Intended For The Detection And/or Differentiation Of Respiratory Viruses Directly From Respiratory Clinical Specimens. The Device Is Intended To Be Performed At The Site Of Sample Collection, Does Not Involve Sample Storage And/or Transport. |