therascreen BRAF V600E RGQ PCR Kit

FDA premarket approval P190026 · decided 2020-04-15

Approval details

PMA number

P190026

Trade name

therascreen BRAF V600E RGQ PCR Kit

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2019-09-30

Decision date

2020-04-15

Days to decision

198 days

Decision code

APPR

Product code

OWD

Advisory committee

Medical Genetics

Expedited review

No

Location

Hilden

Statement

Approval for the therascreen BRAF V600E RGQ PCR Kit. The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mu

510(k) clearances by this applicant