COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0
FDA premarket approval P000012/S009 · decided 2006-06-16
Approval details
- PMA number
- P000012
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2006-01-31
- Decision date
- 2006-06-16
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE EXTENSION OF THE SHELF LIFE TO 24 MONTHS OF THE HCV MASTER MIX, VERSION 2.0, A COMPONENT OF THE COBAS AMPLICOR HCV TEST, V2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLICOR HCV TEST, V2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF HCV RNA IN HUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA). THE TEST DETECTS BY REVERSE TRANSCRIBING TARGET HCV RNA IN COMPLIMENTARY DNA (CDNA), AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR),
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917) | Roche Molecular Systems, Inc. | 2026-07-08 |
| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat CT/NG nucleic acid test (K253756) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) | Roche Molecular Systems, Inc. | 2025-07-31 |