QEP — Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Class II
FDA product code QEP covers "Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections", a Class II medical device regulated under 21 CFR 866.3393. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEP
- Device Class
- Class II
- Regulation Number
- 866.3393
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
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 transmitted infections in conjunction with other clinical and laboratory data.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260917 | roche molecular systems | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on | July 8, 2026 |
| K253756 | roche molecular systems | cobas liat CT/NG nucleic acid test | May 15, 2026 |
| K253759 | roche molecular systems | cobas liat CT/NG/MG nucleic acid test | May 15, 2026 |
| K251501 | visby medical | Visby Medical Men's Sexual Health Test | October 1, 2025 |
| K243343 | bd integrated diagnostic solutions/becton | BD CTGCTV2 | April 22, 2025 |
| K240217 | roche molecular systems | cobas® liat CT/NG nucleic acid test | January 17, 2025 |
| K240197 | roche molecular systems | cobas® liat CT/NG/MG nucleic acid test | January 16, 2025 |
| K230267 | neumodx molecular | NeuMoDx CT/NG Assay 2.0 | December 22, 2023 |
| K220407 | visby medical | Visby Medical Sexual Health Test | March 7, 2023 |
| K222379 | abbott molecular | Alinity m STI Assay | March 3, 2023 |
| K220321 | hologic | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) | June 3, 2022 |
| K210585 | becton, dickinson and | BD CTGCTV2 | May 10, 2022 |
| K202977 | abbott molecular | Alinity m STI Assay | April 29, 2022 |
| K193081 | rheonix | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and soft | December 17, 2021 |
| K200748 | visby medical | Visby Medical Sexual Health | August 26, 2021 |
| K202408 | roche molecular systems | cobas CTNG for use on cobas 6800/8800 systems | January 21, 2021 |
| K200866 | hologic | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | May 17, 2020 |
| K200533 | binx health | binx io CT/NG Assay and binx io CT/NG System | April 27, 2020 |
| K200436 | hologic | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 2 | March 23, 2020 |
| K191352 | binx health | binx health io CT/NG Assay | August 8, 2019 |