510(k) DEN230090
DEN230090 is an FDA 510(k) premarket notification submitted by Nowdiagnostics for the device "First To Know Syphilis Test". The FDA issued a decision of De Novo Granted on August 16, 2024. The device falls under product code SBZ (Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users), a Class II device regulated under 21 CFR 866.3986.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 16, 2024
- Date Received
- December 27, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
- Device Class
- Class II
- Regulation Number
- 866.3986
- Review Panel
- MI
- Submission Type
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.