PMA P110030
- Device
- THERASCREEN KRAS RGQ PCR KIT
- Applicant
- QIAGEN Manchester, Ltd.
- PMA number
- P110030
- Product code
- OWD
- Decision date
- 2012-07-06
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTORGENE 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) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110030B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- THERASCREEN KRAS RGQ PCR KIT
- Applicant
- QIAGEN Manchester, Ltd.
- PMA number
- P110030
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2012-07-06
- Decision code
- APWD
- Date received
- 2011-07-28
- Approval order statement
- APPROVAL FOR THE THERASCREEN KRAS RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN KRAS RGQ PCR KIT IS A REAL-TIME QUALITATIVE PCR ASSAY USED ON THE ROTORGENE 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) BASED ON A KRAS NO MUTATION DETECTED TEST RESULT.