COBAS TAQMAN HCV TEST VERSION 2.0
FDA premarket approval P060030/S006 · decided 2010-09-01
Approval details
- PMA number
- P060030
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS TAQMAN HCV TEST VERSION 2.0
- 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
- 2009-12-22
- Decision date
- 2010-09-01
- Days to decision
- 253 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A MANUAL SPECIMEN PREPARATION OPTION TO THE CURRENTLY APPROVEDAUTOMATED SAMPLE PREPARATION METHOD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND IS INDICATEDFOR:THE COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRONUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA OR SERUM OF HCV-INFECTED INDIVIDUALS USING THE HIGH PURE SYSTEM
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |