510(k) DEN230090

First To Know Syphilis Test by Nowdiagnostics — Product Code SBZ

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.