# DEN230090: First To Know Syphilis Test

- Pathway: De Novo (Direct)
- Applicant: Nowdiagnostics
- Decided: Aug 16, 2024 after 233 days
- Product code: SBZ (Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users)
- Device class: 2
- Regulation: 21 CFR 866.3986
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The First To Know Syphilis Test is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood (capillary). This test is intended for over the counter (OTC) consumer use in individuals suspected of syphilis. Positive test results with the First To Know Syphilis Test alone are not sufficient to diagnose syphilis infection and must be followed by additional laboratory testing through a health care provider to confirm a diagnosis of syphilis. This test is not a substitute for visits to a healthcare provider. The information provided by this product should not be used to start, stop or change any treatments without a healthcare provider. Results of testing with the First To Know Syphilis Test will likely be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. The First To Know Syphilis Test cannot determine whether there has been re-infection with syphilis.

Source page: https://510kreport.com/device/DEN230090
Methodology: https://510kreport.com/methodology