|
Device | THERASCREEN KRAS RGQ PCR KIT |
Generic Name | somatic gene mutation detection system |
Applicant |
QIAGEN GmbH |
qiagen strasse 1 |
hilden 40724 |
|
PMA Number | P110027 |
Date Received | 07/25/2011 |
Decision Date | 05/23/2014 |
Product Code |
OWD
|
Docket Number | 14M-0726 |
Notice Date | 06/10/2014 |
Advisory Committee |
Pathology |
Clinical Trials |
NCT00339183
|
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order 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 IDENTIFICATION OF CRC PATIENTS FOR TREATMENT WITH ERBITUX (CETUXIMAB) AND VECTIBIX (PANITUMUMAB) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|
Supplements: |
S002 S005 S004 S003 S009 S008 S007 S006 S011 S010 |