THERASCEEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Premarket Approval P120022 S001

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

Approval for extending the label claim of the therascreen® egfr rgq pcr kit to include an indication for iressa (gefitinib). The device, as modified, will be marketed under the trade name therascreen® egfr rgq pcr kit and is indicated for:the therascreen® egfr rgq pcr kit is a real-time pcr test for the qualitative detection of exon 19 deletions and exon 21 (l858r) substitution mutations of the epidermal growth factor receptor (egfr) gene in dna derived from formalin-fixed paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tumor tissue. The test is intended to be used to select patients with nsclc for whom gilotrif (afatinib) or iressa (gefitinib), egfr tyrosine kinase inhibitors (tkis), is indicated. Safety and efficacy of gilotrif (afatinib) and iressa (gefitinib) have not been established in the patients whose tumors have l861q, g719x, s768i, exon 20 insertions, and t790m mutations, which are also detected by the therascreen egfr rgq pcr kit. Specimens are processed using the qiaamp dsp dna ffpe tissue kit for manual sample preparation and the rotor-gene q mdx instrument for automated amplification and detection.

DeviceTHERASCEEN EGFR RGQ PCR KIT
Classification NameSomatic Gene Mutation Detection System
Generic NameSomatic Gene Mutation Detection System
ApplicantQIAGEN MANCHESTER LTD
Date Received2014-09-18
Decision Date2015-07-10
PMAP120022
SupplementS001
Product CodeOWD
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6

Supplemental Filings

Supplement NumberDateSupplement Type
P120022Original Filing
S022 2020-10-23 Real-time Process
S021 2020-03-04 30-day Notice
S020 2019-08-28 Special (immediate Track)
S019 2018-03-08 30-day Notice
S018 2018-02-16 Normal 180 Day Track
S017 2018-01-26 30-day Notice
S016 2017-07-28 Normal 180 Day Track
S015 2017-06-29 30-day Notice
S014 2016-12-28 Normal 180 Day Track
S013 2016-08-10 30-day Notice
S012 2015-09-28 Normal 180 Day Track No User Fee
S011
S010 2015-02-18 Normal 180 Day Track
S009 2015-01-26 Real-time Process
S008 2015-01-26 Real-time Process
S007 2015-01-21 30-day Notice
S006 2015-01-21 30-day Notice
S005 2014-12-22 30-day Notice
S004 2014-12-15 30-day Notice
S003
S002 2014-11-19 30-day Notice
S001 2014-09-18 Normal 180 Day Track

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