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Therascreen PDGFRA RGQ PCR Kit

FDA PMA

Class III (US FDA PMA)

PMA P210002

by QIAGEN GmbH

Identity

Trade Name
therascreen PDGFRA RGQ PCR Kit FDA PMA
Generic Name
Somatic gene mutation detection system FDA PMA

Identifiers

PMA Number
P210002 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 PDGFRA RGQ PCR Kit is a real-time qualitative in vitro diagnostic assay designed for the detection of the D842V somatic mutation in the PDGFRA gene. It utilizes genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue obtained from patients diagnosed with Gastrointestinal Stromal Tumor (GIST). This test serves as a companion diagnostic to assist clinicians in identifying patients who may be eligible for treatment with AYVAKIT (avapritinib).

This assay is intended for use by trained personnel within a professional laboratory environment. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation, followed by automated amplification and detection on the Rotor-Gene Q (RGQ) MDx instrument. The device has received FDA PMA approval for its intended clinical application.

Frequently asked questions

What is the primary purpose of the Therascreen PDGFRA RGQ PCR Kit?

The kit is a companion diagnostic test used to detect the D842V somatic mutation in the PDGFRA gene, which helps clinicians identify GIST patients who may be eligible for treatment with AYVAKIT.

What type of patient samples are required for this test?

The assay requires genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue samples collected from patients with Gastrointestinal Stromal Tumor.

Is this test suitable for use in any laboratory setting?

No, the kit is specifically intended for use by trained personnel in a professional laboratory environment using the specified Rotor-Gene Q MDx instrument.

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 P210002 24 fields · synced Sep 18, 2026