Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
The Nucleic Acid Detection System For 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 microorganisms in clinical specimens from patients suspected of sexually transmitted infections, used as an aid to diagnosis in conjunction with other clinical and laboratory data. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3393 in the Microbiology specialty. The product code is QEP. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEP
- Device Class
- FDA class 2
- Regulation Number
- 866.3393
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253759 | cobas liat CT/NG/MG nucleic acid test | May 15, 2026 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K253756 | cobas liat CT/NG nucleic acid test | May 15, 2026 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K251501 | Visby Medical Men's Sexual Health Test | Oct 01, 2025 | Substantially Equivalent | Visby Medical, Inc. |
| K243343 | BD CTGCTV2 | Apr 22, 2025 | Substantially Equivalent | Bd Integrated Diagnostic Solutions/Becton, |
| K240217 | cobas® liat CT/NG nucleic acid test | Jan 17, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Jan 16, 2025 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Dec 22, 2023 | Substantially Equivalent | Neumodx Molecular, Inc. |
| K220407 | Visby Medical Sexual Health Test | Mar 07, 2023 | Substantially Equivalent | Visby Medical |
| K222379 | Alinity m STI Assay | Mar 03, 2023 | Substantially Equivalent | Abbott Molecular, Inc. |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris | Jun 03, 2022 | Substantially Equivalent | Hologic, Inc. |
| K210585 | BD CTGCTV2 | May 10, 2022 | Substantially Equivalent | Becton, Dickinson and Company |
| K202977 | Alinity m STI Assay | Apr 29, 2022 | Substantially Equivalent | Abbott Molecular, Inc. |
| K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit | Dec 17, 2021 | Substantially Equivalent | Rheonix, Inc. |
| K200748 | Visby Medical Sexual Health | Aug 26, 2021 | Substantially Equivalent | Visby Medical |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | Jan 21, 2021 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | May 17, 2020 | Substantially Equivalent | Hologic, Inc. |
| K200533 | binx io CT/NG Assay and binx io CT/NG System | Apr 27, 2020 | Substantially Equivalent | Binx Health, Inc. |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | Mar 23, 2020 | Substantially Equivalent | Hologic, Inc. |
| K191352 | binx health io CT/NG Assay | Aug 08, 2019 | Substantially Equivalent | Binx Health, Inc. |
| K190515 | Aptima Combo 2 Assay (Panther System) | May 23, 2019 | Substantially Equivalent | Hologic, Inc. |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit | May 23, 2019 | Substantially Equivalent | Cepheid |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | May 22, 2019 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| DEN180047 | Aptima Mycoplasma genitalium Assay | Jan 23, 2019 | Unknown | Hologic, Inc. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.