HBV ASSAY
FDA premarket approval P080026/S006 · decided 2013-10-15
Approval details
- PMA number
- P080026
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HBV ASSAY
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2013-02-15
- Decision date
- 2013-10-15
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR 1) THE ADDITION OF AN OPTIONAL EXTENDED USE FEATURE TO ALLOW PREPARED AMPLIFICATION MASTER MIX AND INTERNAL CONTROL TO BE USED SECOND TIME WITHIN 14 DAYS OF INITIAL USE IF STORED AT 2°C TO 8°C; 2) IMPROVEMENTS TO THE PREPARATION AND PROCESSING STEPS OF THE AMPLIFICATION MASTER MIX BY THE ABBOTT M2000SP INSTRUMENT; AND 3) ASSOCIATED SOFTWARE REVISIONS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
| Alinity m EBV (09N43-095) (K243489) | Abbott Molecular, Inc. | 2025-07-28 |
| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| 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 |