510(k) K220321
- Device
- 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
- Applicant
- Hologic, Inc.
- 510(k) number
- K220321
- Product code
- QEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-03
- Date received
- 2022-02-03
- Regulation
- 866.3393
- Classification name
- Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jill Wyland
- Address
- 10210 Genetic Center Dr. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3019837962
- 3012598266
- 3010749841
- 3009613136
- 3004141078
- 2243471
- 2024800
- 2436875
- 3004530258
- 3016838963
- 9610126
- 3005248192
- 3003795116
- 3003630504
- 3002444944
- 1181121
- 3025663244
- 3017907743
- 3016608638
- 3013019728
- 1119779
- 3007420875
- 3038610665
Source Documents#
Other 510(k) Records For Product Code QEP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 |
| K251501 | Visby Medical Men's Sexual Health Test | Visby Medical, Inc. | 2025-10-01 |
| K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 |
| K240217 | cobas® liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-17 |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2025-01-16 |
| K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | 2023-12-22 |
| K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023-03-07 |
| K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023-03-03 |
| K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022-05-10 |
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022-04-29 |
| K193081 | Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit | Rheonix, Inc. | 2021-12-17 |
| K200748 | Visby Medical Sexual Health | Visby Medical | 2021-08-26 |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021-01-21 |
| K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. | 2020-05-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases