THERASCEEN EGFR RGQ PCR KIT

FDA premarket approval P120022/S001 · decided 2015-07-10

Approval details

PMA number

P120022

Supplement

S001

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

THERASCEEN EGFR RGQ PCR KIT

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2014-09-18

Decision date

2015-07-10

Days to decision

295 days

Decision code

APPR

Product code

OWD

Advisory committee

Pathology

Expedited review

No

Location

Hilden

Statement

APPROVAL FOR EXTENDING THE LABEL CLAIM OF THE THERASCREEN® EGFR RGQ PCR KIT TO INCLUDE AN INDICATION FOR IRESSA (GEFITINIB). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERASCREEN® EGFR RGQ PCR KIT AND 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 (FFP

510(k) clearances by this applicant