Aptima
The filing covers Aptima Combo 2 and Aptima Trichomonas vaginalis assays for use on Panther and Tigris systems. The change assessed in this submission is a ready-made reagent format; the…
The filing covers Aptima Combo 2 and Aptima Trichomonas vaginalis assays for use on Panther and Tigris systems. The change assessed in this submission is a ready-made reagent format; the filing states that it does not change either assay’s principle of procedure, intended use or primary technological characteristics.
Aptima Combo 2 detects and differentiates ribosomal RNA from Chlamydia trachomatis and Neisseria gonorrhoeae to aid diagnosis. The Trichomonas vaginalis assay detects its target RNA to aid diagnosis of trichomoniasis. The filing identifies the assays as qualitative nucleic-acid tests on the named platforms.
Listed Item
Aptima® Mycoplasma genitalium Assay, 100 test, box 2 of 2 (15°C to 30°C box).
Assay Targets and Format
The submission covers ready-made amplification, enzyme and probe reagents. It retains assay-specific indications and specimen types for the Panther and Tigris systems, including listed swab and urine specimens.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | QEP |
| Device type | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3393 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K200436 |
| Record published | 2022-07-28 |
| Record revised | 2024-06-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC2, ROOM TEMP, 250T, READY MADE | In distribution | |
| KIT, BX 2 (RT) M GEN, 100T, AS, IVD | In distribution | |
| KIT, M GEN, CALIBRATOR 100T, AS, IVD | In distribution | |
| KIT, BX 1 (REF) M GEN, 100T, AS, IVD | In distribution | |
| KIT, M GEN PANEL B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alinity m | Abbott Molecular, Inc. | 4 |
| Xpert CT/NG | Cepheid | 2 |
| cobas® TV/MG | Roche Molecular Systems, Inc. | 2 |
| Aptima Combo 2® | Hologic, Inc. | 2 |
| cobas® TV/MG Positive Control Kit | Roche Molecular Systems, Inc. | 2 |
| binx io | Binx Health, Ltd. | 1 |
| Visby Medical Men’s Sexual Health Test | Visby Medical, Inc. | 1 |
| BD COR CTGCTV2 US | Becton, Dickinson AND Company | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220321 | 2022-06-03 |
| K200866 | 2020-05-17 |
| K200436 | 2020-03-23 |
| K190515 | 2019-05-23 |
| DEN180047 | 2019-01-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.