COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
FDA premarket approval P050028/S004 · decided 2010-09-09
Approval details
- PMA number
- P050028
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2009-07-01
- Decision date
- 2010-09-09
- Days to decision
- 435 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A DEVICE DESIGN MODIFICATION THAT INCLUDES REAGENTS, DISPOSABLES,AND INSTRUMENTATION, TO AUTOMATE THE MANUAL SAMPLE PREPARATION PROCESS CURRENTLY USED BY THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THE DEVICE, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0AND IS INDICATED FOR:THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 IS AN IN VITRO NUCLEIC ACIDAMPLIFICATION LEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA
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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 |