therascreen FGFR RGQ RT-PCR Kit

FDA premarket approval P180043/S001 · decided 2020-08-18

Approval details

PMA number

P180043

Supplement

S001

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

therascreen FGFR RGQ RT-PCR Kit

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2020-02-28

Decision date

2020-08-18

Days to decision

172 days

Decision code

APPR

Product code

OWD

Advisory committee

Medical Genetics

Expedited review

No

Location

Hilden

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 f

510(k) clearances by this applicant