CRCDx RAS Mutation Detection Assay Kit
FDA premarket approval P220005 · decided 2023-09-29
Approval details
- PMA number
- P220005
- Trade name
- CRCDx RAS Mutation Detection Assay Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- Entrogen, Inc.
- Date received
- 2022-04-20
- Decision date
- 2023-09-29
- Days to decision
- 527 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Woodland Hills, CA
- 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) ba
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.