PMA P110027S017

Device: therascreen® KRAS RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S017
Product code: OWD
Decision date: 2024-06-21
Classification: Pathology
Generic name: Somatic gene mutation detection system
Approval order statement: Approval for expanding the indication to aid in the identification of colorectal cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with KRAZATI (adagrasib) in combination with ERBITUX (cetuximab)

Current openFDA PMA Record#

Device: therascreen® KRAS RGQ PCR Kit
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S017
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2024-06-21
Decision code: APPR
Date received: 2024-02-07
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the indication to aid in the identification of colorectal cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with KRAZATI (adagrasib) in combination with ERBITUX (cetuximab)