Alinity m EBV (09N43-095)
FDA 510(k) clearance K243489 · decided 2025-07-28
Clearance details
- K-number
- K243489
- Device name
- Alinity m EBV (09N43-095)
- Applicant
- Abbott Molecular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-11-12
- Decision date
- 2025-07-28
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- QLX
- Device class
- 2
- Regulation number
- 866.3183
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Des Plaines, IL, 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 |
|---|---|---|
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |
| cobas BKV (K203220) | Roche Molecular Systems, Inc. | 2021-01-29 |
| cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (DEN200015) | Roche Molecular Systems, Inc. | 2020-07-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HR HPV (P230003/S009) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HBV (P200013/S027) | Abbott Molecular, Inc. | 2025-10-17 |
| Alinity m HR HPV (P230003/S008) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HBV (P200013/S026) | Abbott Molecular, Inc. | 2025-09-24 |
| Alinity m HR HPV (P230003/S006) | Abbott Molecular, Inc. | 2025-09-10 |
| Vysis CLL Fish Probe Kit (P150041/S007) | Abbott Molecular, Inc. | 2025-08-08 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S022) | Abbott Molecular, Inc. | 2025-08-05 |
| Alinity m HR HPV (P230003/S007) | Abbott Molecular, Inc. | 2025-04-18 |