PMA P110027S012

Device: therascreen KRAS RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S012
Product code: OWD
Decision date: 2021-05-28
Generic name: Somatic gene mutation detection system
Approval order statement: Approval for expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with LUMAKRA (sotorasib).

Current openFDA PMA Record#

Device: therascreen KRAS RGQ PCR KIT
Applicant: QIAGEN GmbH
PMA number: P110027
Supplement: S012
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2021-05-28
Decision code: APPR
Date received: 2021-02-10
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor KRAS G12C mutations and may benefit from treatment with LUMAKRA (sotorasib).