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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Devicetherascreen FGFR RGQ RT-PCR Kit
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
QIAGEN GmbH
qiagen strasse 1
hilden 
PMA NumberP180043
Date Received11/08/2018
Decision Date04/12/2019
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 19M-1979
Notice Date 04/26/2019
Advisory Committee Molecular Genetics
Clinical Trials NCT02365597
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the THERASCREEN® FGFR RGQ PCR KIT. The Therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying urothelial cancer (UC) patients who harbor these alterations and are therefore eligible for treatment with BALVERSA (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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