DEN240020 is an FDA 510(k) submission for the Visby Medical Women's Sexual Health Test. This device is classified as a Test For Detection Of Microorganism(s) Causing Sexually Transmitted Infections Performed By Lay Users (Class II - Special Controls, product code SEA).
Submitted by Visby Medical, Inc. (San Jose, US). The FDA issued a Not Cleared (DENG) decision on March 28, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3386. This Device Is An In Vitro Diagnostic Device For The Detection And/or Differentiation Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Test Is Intended For Prescription Or Over-the-counter Use..
| 510(k) Number | DEN240020 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 13, 2024 |
| Decision Date | March 28, 2025 |
| Days to Decision | 319 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | SEA - Test For Detection Of Microorganism(s) Causing Sexually Transmitted Infections Performed By Lay Users |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3386 |
| Definition | This Device Is An In Vitro Diagnostic Device For The Detection And/or Differentiation Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Test Is Intended For Prescription Or Over-the-counter Use. |