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
FDA 510(k) clearance K220321 · decided 2022-06-03
Clearance details
- K-number
- K220321
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-03
- Decision date
- 2022-06-03
- Days to decision
- 120 days
- Clearance type
- Special
- Product code
- QEP
- Device class
- 2
- Regulation number
- 866.3393
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hologic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917) | Roche Molecular Systems, Inc. | 2026-07-08 |
| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat CT/NG nucleic acid test (K253756) | Roche Molecular Systems, Inc. | 2026-05-15 |
| Visby Medical Men's Sexual Health Test (K251501) | Visby Medical, Inc. | 2025-10-01 |
| BD CTGCTV2 (K243343) | Bd Integrated Diagnostic Solutions/Becton, | 2025-04-22 |
| cobas® liat CT/NG nucleic acid test (K240217) | Roche Molecular Systems, Inc. | 2025-01-17 |
| cobas® liat CT/NG/MG nucleic acid test (K240197) | Roche Molecular Systems, Inc. | 2025-01-16 |
| NeuMoDx CT/NG Assay 2.0 (K230267) | Neumodx Molecular, Inc. | 2023-12-22 |
| Visby Medical Sexual Health Test (K220407) | Visby Medical | 2023-03-07 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| BD CTGCTV2 (K210585) | Becton, Dickinson and Company | 2022-05-10 |
| Alinity m STI Assay (K202977) | Abbott Molecular, Inc. | 2022-04-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
| Envision Mammography Platform (P080003/S011) | Hologic, Inc. | 2025-11-24 |
| Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (P170025/S023) | Hologic, Inc. | 2025-10-07 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S041) | Hologic, Inc. | 2025-08-27 |
| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |