Aptima HCV Quant Dx Assay
FDA 510(k) clearance K233352 · decided 2024-07-24
Clearance details
- K-number
- K233352
- Device name
- Aptima HCV Quant Dx Assay
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-07-24
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- MZP
- Device class
- 2
- Regulation number
- 866.3170
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| cobas HCV (K221007) | Roche Molecular Systems, Inc. | 2022-11-04 |
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 |