PMA P140023S004

Device: COBAS KRAS MUTATION TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P140023
Supplement: S004
Product code: OWD
Decision date: 2016-09-24
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cetuximab) or with Vectibix® (panitumumab) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cetuximab) or Vectibix® (panitumumab) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.

Current openFDA PMA Record#

Device: COBAS KRAS MUTATION TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P140023
Supplement: S004
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2016-09-24
Decision code: APPR
Date received: 2016-02-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cetuximab) or with Vectibix® (panitumumab) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cetuximab) or Vectibix® (panitumumab) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.