QEP — Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Class II
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 |
|---|---|---|---|
| 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 |
| K190441 | cepheid | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity- | May 23, 2019 |
| K190515 | hologic | Aptima Combo 2 Assay (Panther System) | May 23, 2019 |
| K190433 | roche molecular systems | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit | May 22, 2019 |