Visby Medical Men's Sexual Health Test
FDA 510(k) K251501 · Visby Medical, Inc.
Submission
- Device name
- Visby Medical Men's Sexual Health Test
- Applicant
- Visby Medical, Inc.
San Jose, CA, US - Received
- May 15, 2025
- Decision date
- October 1, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3393
- Specialty
- Microbiology
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually…
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| K230267 | NeuMoDx CT/NG Assay 2.0QEP · Traditional | Neumodx Molecular, Inc. | 12/22/2023SE |
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| K222379 | Alinity m STI AssayQEP · Traditional | Abbott Molecular, Inc. | 03/03/2023SE |
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More from Hologic, Inc.
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|---|---|---|
| K253971 | Visby Medical Flu and COVID-19 TestSIA · Traditional | 05/27/2026SE |
| K242526 | Visby Medical Respiratory Health TestQOF · Dual Track | 02/19/2025SE |
| K220407 | Visby Medical Sexual Health TestQEP · Dual Track | 03/07/2023SE |
| K200748 | Visby Medical Sexual HealthQEP · Dual Track | 08/26/2021SE |
Questions and answers
When was Visby Medical Men's Sexual Health Test cleared by the FDA?
Visby Medical Men's Sexual Health Test (K251501) received a 510(k) decision of Substantially Equivalent on October 1, 2025, 139 days after the submission was received.
What is the product code of K251501?
The FDA product code is QEP – Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, a Class II (moderate risk) device regulated under 21 CFR 866.3393.