therascreen PDGFRA RGQ PCR Kit

FDA premarket approval P210002 · decided 2023-06-29

Approval details

PMA number

P210002

Trade name

therascreen PDGFRA RGQ PCR Kit

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2021-01-29

Decision date

2023-06-29

Days to decision

881 days

Decision code

APPR

Product code

OWD

Advisory committee

Medical Genetics

Expedited review

No

Location

Hilden

Statement

Approval for the therascreen PDGFRA RGQ PCR Kit. The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a real-time qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patients formalin-fixed paraffin-embedded (FFPE) tumor tissue. The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may b

510(k) clearances by this applicant