Aptima HBV Quant Assay
FDA premarket approval P170025/S019 · decided 2024-06-17
Approval details
- PMA number
- P170025
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aptima HBV Quant Assay
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Hologic, Inc.
- Date received
- 2023-09-29
- Decision date
- 2024-06-17
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for 1) use of Aptima HBV Quant Assay using new estimated background minimum limits to detect, flag and invalidate test results due to a faulty lamp and 2) increase reagent on-board/off-board cycles from 5 cycles to 8 cycles
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |