COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0
FDA premarket approval P060030/S027 · decided 2013-02-14
Approval details
- PMA number
- P060030
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN 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
- 2012-07-02
- Decision date
- 2013-02-14
- Days to decision
- 227 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR DEVICE DESIGN MODIFICATIONS TO REDUCE THE SAMPLE INPUT VOLUME, IMPROVE GENOTYPE INCLUSIVITY, AND IMPROVE ASSAY SENSITIVITY TO 15 IU/ML. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 AND IS INDICATED FOR: THE COBAS® AMPLIPREP/COBAS® TAQMAN® HCV TEST, V2.0 IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA GENOTYPES 1 TO 6 IN HUMAN EDTA PLASMA OR SERUM OF HCV-INFECTED INDIVI
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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 |