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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Devicetherascreen KRAS RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hiden 40724
PMA NumberP110027
Supplement NumberS012
Date Received02/10/2021
Decision Date05/28/2021
Product Code OWD 
Docket Number 21M-0531
Notice Date 06/03/2021
Advisory Committee Pathology
Clinical TrialsNCT03600883
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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