Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST
FDA premarket approval P110020/S016 · decided 2016-11-07
Approval details
- PMA number
- P110020
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2016-06-30
- Decision date
- 2016-11-07
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the cobas® 4800 BRAF V600 Mutation Test. The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas® 4800 System, and is intended to be used as an aid in selecting melanoma patients for treatment with the targeted therapies listed in the table below, in a
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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 |