therascreen KRAS RGQ PCR KIT

FDA Premarket Approval P110027 S012

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.

Pre-market Approval Supplement Details

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 lumakras™ (sotorasib).

Devicetherascreen KRAS RGQ PCR KIT
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN GmbH
Date Received2021-02-10
Decision Date2021-05-28
Product CodeOWD 
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN GmbH qiagen Strasse 1 hilden 40724

Supplemental Filings

Supplement NumberDateSupplement Type
P110027Original Filing
S012 2021-02-10 Panel Track
S011 2020-03-04 30-day Notice
S010 2018-03-08 30-day Notice
S009 2015-08-18 Normal 180 Day Track No User Fee
S008 2015-02-18 Normal 180 Day Track
S007 2015-01-26 Real-time Process
S006 2015-01-26 Real-time Process
S005 2015-01-21 30-day Notice
S004 2015-01-21 30-day Notice
S003 2014-12-22 30-day Notice
S002 2014-12-15 30-day Notice

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