THERASCREEN EGFR RGQ PCR KIT

FDA premarket approval P120022 · decided 2013-07-12

Approval details

PMA number

P120022

Trade name

THERASCREEN EGFR RGQ PCR KIT

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2012-11-30

Decision date

2013-07-12

Days to decision

224 days

Decision code

APPR

Product code

OWD

Advisory committee

Pathology

Expedited review

Yes

Location

Hilden

Statement

APPROVAL FOR THE THERASCREEN® EGFR RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NONSMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRJF (AFATINIB), AN EGFR TYROSINE K

510(k) clearances by this applicant