# DEN240020: Visby Medical Women's Sexual Health Test

- Pathway: De Novo (Direct)
- Applicant: Visby Medical, Inc.
- Decided: Mar 28, 2025 after 319 days
- Product code: SEA (Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users)
- Device class: 2
- Regulation: 21 CFR 866.3386
- 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 Visby Medical Women's Sexual Health Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected vaginal swab specimens. This test is intended to be sold over-the-counter (OTC) for use by females suspected of sexually transmitted infection with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. 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.

Source page: https://510kreport.com/device/DEN240020
Methodology: https://510kreport.com/methodology