DEN230090 is an FDA 510(k) submission for the First To Know Syphilis Test. This device is classified as a Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users (Class II - Special Controls, product code SBZ).
Submitted by Nowdiagnostics (Springdale, US). The FDA issued a Not Cleared (DENG) decision on August 16, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3986. Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users Is An In Vitro Diagnostic Device Used For Detection Of Antibodies In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Device Is Intended To Aid In Diagnosis Of Syphilis And Intended For Prescription Use Or Over-the-counter Use..
| 510(k) Number | DEN230090 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 27, 2023 |
| Decision Date | August 16, 2024 |
| Days to Decision | 233 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | SBZ - Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3986 |
| Definition | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users Is An In Vitro Diagnostic Device Used For Detection Of Antibodies In Clinical Specimens For Use In Home Settings, Or Similar Environments. The Device Is Intended To Aid In Diagnosis Of Syphilis And Intended For Prescription Use Or Over-the-counter Use. |