COBAS KRAS MUTATION TEST
FDA premarket approval P140023 · decided 2015-05-07
Approval details
- PMA number
- P140023
- Trade name
- COBAS KRAS MUTATION TEST
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2014-10-23
- Decision date
- 2015-05-07
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE COBAS KRAS MUTATION TEST. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE COBAS KRAS MUTATION TEST, FOR USE WITH THE COBAS 4800 SYSTEM, IS A REAL-TIME PCR TEST FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN CODONS 12 AND 13 OF THE KRAS GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED HUMAN COLORECTAL CANCER (CRC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED AS AN AID IN THE IDENTIFICATION OF CRC PATIENTS FOR WHOM TREATMENT WITH ERBITUX (CETUXIMAB) OR WITH VECTIBIX (PAN
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510(k) clearances by this applicant
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