Somatic Gene Mutation Detection System
Basic Information
- Device Name
- Somatic Gene Mutation Detection System
- Trade Name
- therascreen FGFR RGQ RT-PCR Kit
- PMA Number
- P180043
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- OWD
- Generic Name
- Somatic gene mutation detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Medical Genetics
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 18, 2020
- Date Received
- February 28, 2020
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the therascreen FGFR RGQ RT-PCR Kit is a reverse transcription, real-time 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWD | Somatic Gene Mutation Detection System | FDA class 3 | Unknown |