therascreen EGFR RGQ PCR Kit

FDA premarket approval P120022/S018 · decided 2018-09-27

Approval details

PMA number

P120022

Supplement

S018

Supplement type

Normal 180 Day Track

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

therascreen EGFR RGQ PCR Kit

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2018-02-16

Decision date

2018-09-27

Days to decision

223 days

Decision code

APPR

Product code

OWD

Advisory committee

Pathology

Expedited review

No

Location

Hilden

Statement

Approval for to extend the intended use of the therascreen® EGFR RGQ PCR Kit to include the selection of patients with NSCLC for whom dacomitinib is indicated.

510(k) clearances by this applicant