PMA P220005
- Device
- CRCDx RAS Mutation Detection Assay Kit
- Applicant
- Entrogen, Inc.
- PMA number
- P220005
- Product code
- OWD
- Decision date
- 2023-09-29
- Classification
- Pathology
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Approval for the CRCdx® RAS Mutation Detection Kit. The device is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (mCRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a no mutation detected test result in accordance with the approved therapeutic product labeling.
Current openFDA PMA Record#
- Device
- CRCDx RAS Mutation Detection Assay Kit
- Applicant
- Entrogen, Inc.
- PMA number
- P220005
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2023-09-29
- Decision code
- APPR
- Date received
- 2022-04-20
- Approval order statement
- Approval for the CRCdx® RAS Mutation Detection Kit. The device is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (mCRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a no mutation detected test result in accordance with the approved therapeutic product labeling.