Visby Medical Sexual Health Test
FDA 510(k) K220407 · Visby Medical
Submission
- Device name
- Visby Medical Sexual Health Test
- Applicant
- Visby Medical
San Jose, CA, US - Received
- February 14, 2022
- Decision date
- March 7, 2023
- 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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| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | Roche Molecular Systems, Inc. | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 05/15/2026SE |
| K251501 | Visby Medical Men's Sexual Health TestQEP · Dual Track | Visby Medical, Inc. | 10/01/2025SE |
| K243343 | BD CTGCTV2QEP · Traditional | Bd Integrated Diagnostic Solutions/Becton, | 04/22/2025SE |
| K240217 | cobas® liat CT/NG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 01/17/2025SE |
| K240197 | cobas® liat CT/NG/MG nucleic acid testQEP · Dual Track | Roche Molecular Systems, Inc. | 01/16/2025SE |
| K230267 | NeuMoDx CT/NG Assay 2.0QEP · Traditional | Neumodx Molecular, Inc. | 12/22/2023SE |
| K222379 | Alinity m STI AssayQEP · Traditional | Abbott Molecular, Inc. | 03/03/2023SE |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…QEP · Special | Hologic, Inc. | 06/03/2022SE |
More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253971 | Visby Medical Flu and COVID-19 TestSIA · Traditional | 05/27/2026SE |
| K251501 | Visby Medical Men's Sexual Health TestQEP · Dual Track | 10/01/2025SE |
| K242526 | Visby Medical Respiratory Health TestQOF · Dual Track | 02/19/2025SE |
| K200748 | Visby Medical Sexual HealthQEP · Dual Track | 08/26/2021SE |
Questions and answers
When was Visby Medical Sexual Health Test cleared by the FDA?
Visby Medical Sexual Health Test (K220407) received a 510(k) decision of Substantially Equivalent on March 7, 2023, 386 days after the submission was received.
What is the product code of K220407?
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.