DEN240029 is an FDA 510(k) submission for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. This device is classified as a Multi-analyte Respiratory Virus Antigen Detection Test (Class II - Special Controls, product code SCA).
Submitted by Healgen (Houston, US). The FDA issued a Not Cleared (DENG) decision on October 7, 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 | DEN240029 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 07, 2024 |
| Decision Date | October 07, 2024 |
| Days to Decision | 122 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| 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. |