ABBOTT REAL TIME HCV
FDA premarket approval P100017/S005 · decided 2013-09-25
Approval details
- PMA number
- P100017
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT REAL TIME HCV
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2013-03-01
- Decision date
- 2013-09-25
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR THE ADDITION OF AN OPTIONAL EXTENDED USE FEATURE TO ALLOW PREPARED AMPLIFICATION MASTER MIX AND INTERNAL CONTROL TO BE USED A SECOND TIME WITHIN 14 DAYS OF INITIAL USE IF STORED AT -25°C TO -15°C; 2) PROCESS IMPROVEMENTS TO THE LIQUID LEVEL SENSING PERFORMED BY THE ABBOTT M2000SP INSTRUMENT; 3) THE CONVERSION OF MANUAL PLATE FILLING TO AUTOMATED PLATE FILLING; AND 4) 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 |