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Therascreen FGFR RGQ RT-PCR Kit

FDA PMA

Class III (US FDA PMA)

PMA P180043

by QIAGEN GmbH

Identity

Trade Name
therascreen FGFR RGQ RT-PCR Kit FDA PMA
Generic Name
Somatic gene mutation detection system FDA PMA

Identifiers

PMA Number
P180043 FDA PMA
FDA Product Code
OWD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Medical Genetics FDA PMA
FDA Decision
APPR Approved FDA PMA

The Therascreen FGFR RGQ RT-PCR Kit is a real-time reverse transcription polymerase chain reaction (RT-PCR) system designed for the qualitative detection of specific somatic mutations and fusions in the fibroblast growth factor receptor 3 (FGFR3) gene. It identifies two point mutations in exon 7 (p.R248C and p.S249C), two point mutations in exon 10 (p.G370C and p.Y373C), and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) within RNA extracted from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue.

This kit is intended for use in molecular diagnostics laboratories, requiring manual sample preparation with the RNeasy DSP FFPE Kit followed by reverse transcription and automated amplification on the Rotor-Gene Q MDx (US) instrument. It is supplied as a single-use diagnostic device and is authorized under an FDA Premarket Approval (PMA). The test aids in identifying urothelial cancer patients eligible for targeted therapy with erdafitinib, though its use is not limited to this indication.

Frequently asked questions

What is the purpose of the therascreen FGFR RGQ RT-PCR Kit?

The kit is designed for the qualitative detection of specific somatic mutations and fusions in the FGFR3 gene within RNA extracted from FFPE urothelial tumor tissue, helping identify patients eligible for targeted therapy with erdafitinib.

How is the therascreen FGFR RGQ RT-PCR Kit supplied?

The kit is supplied as a single-use diagnostic device that requires manual sample preparation with the RNeasy DSP FFPE Kit, followed by reverse transcription and automated amplification on the Rotor-Gene Q MDx (US) instrument.

What specific mutations and fusions does the therascreen FGFR RGQ RT-PCR Kit detect?

The kit detects two point mutations in exon 7 (p.R248C and p.S249C), two point mutations in exon 10 (p.G370C and p.Y373C), and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the FGFR3 gene.

What type of tissue samples can be used with the therascreen FGFR RGQ RT-PCR Kit?

The kit is designed to work with RNA extracted from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue samples.

What is the regulatory status of the therascreen FGFR RGQ RT-PCR Kit?

The kit is authorized under an FDA Premarket Approval (PMA) with the PMA number P180043, indicating it has received FDA approval for its intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
QIAGEN GmbH

Sources (1)

  • FDA PMA P180043 24 fields · synced Sep 18, 2026