SBZ · Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
Microbiology · 21 CFR 866.3986 · Class 2
Overview
| Product Code | SBZ |
|---|---|
| Device Name | Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users |
| Regulation | 21 CFR 866.3986 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
The First To Know Syphilis Test is a single-use, qualitative, rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human capillary whole blood. It is intended for over-the-counter (OTC) consumer use in individuals suspected of syphilis. The test is visually read and does not require software, instrumentation, or additional reagents.
Classification Rationale
Class II (special controls). The device is classified as Class II under 21 CFR 866.3986, as general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but the risks can be mitigated by special controls.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230090 | First To Know Syphilis Test | Nowdiagnostics | Aug 16, 2024 | DENG |
Top Applicants
- Nowdiagnostics — 1 clearance
