Aptima SARS-CoV-2 Assay
FDA 510(k) clearance K243396 · decided 2025-02-13
Clearance details
- K-number
- K243396
- Device name
- Aptima SARS-CoV-2 Assay
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-31
- Decision date
- 2025-02-13
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- QQX
- Device class
- 2
- Regulation number
- 866.3981
- 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® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867) | Roche Molecular Systems, Inc. | 2025-02-11 |
| Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109) | Cepheid® | 2025-01-15 |
| Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) | Abbott Molecular | 2024-12-06 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| Xpert® Xpress CoV-2 plus (K230440) | Cepheid® | 2023-10-13 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306) | Roche Molecular Systems, Inc. | 2023-06-01 |
| cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (K213804) | Roche Molecular Systems, Inc. | 2022-10-22 |
| Simplexa COVID-19 Direct (K212147) | Diasorin Molecular, LLC | 2022-09-13 |
| BioFire COVID-19 Test 2 (K221460) | Biofire Defense, LLC | 2022-07-25 |
| BioFire COVID-19 Test 2 (K211079) | Biofire Defense, LLC | 2021-11-01 |
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 |