THERASCREEN KRAS RGQ PCR KIT

FDA premarket approval P110027 · decided 2014-05-23

Approval details

PMA number

P110027

Trade name

THERASCREEN KRAS RGQ PCR KIT

Generic name

Somatic gene mutation detection system

Applicant

QIAGEN GmbH

Date received

2011-07-25

Decision date

2014-05-23

Days to decision

1033 days

Decision code

APPR

Product code

OWD

Advisory committee

Pathology

Expedited review

No

Location

Hilden

Statement

APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT, WHICH IS TO BE USED AS A COMPANION DIAGNOSTIC FOR THE DRUG VECTIBIX (PANITUMUMAB). THIS DEVICE IS INDICATED FOR:THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTOR-GENE Q MDX INSTRUMENT FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN THE HUMAN KRAS ONCOGENE, USING DNA EXTRACTED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE), COLORECTAL CANCER (CRC) TISSUE. THE THERASCREEN KRAS RGQ PCR KIT IS INTENDED TO AID IN THE I

510(k) clearances by this applicant