Cobas Kras Mutation Test

FDA premarket approval P140023 · Somatic gene mutation detection system

PMA numberP140023

Approval

Applicant
Roche Molecular Systems, Inc.
Received
October 23, 2014
Decision date
May 7, 2015 (APPR)
Supplements
32, latest March 17, 2026
Product code
OWD – Somatic Gene Mutation Detection System

Official FDA PMA record

Approval order statement

APPROVAL FOR THE COBAS KRAS MUTATION TEST. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE COBAS KRAS MUTATION TEST, FOR USE WITH THE COBAS 4800 SYSTEM, IS A REAL-TIME PCR TEST FOR THE DETECTION OF SEVEN SOMATIC MUTATIONS IN CODONS 12 AND 13 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 FOR WHOM TREATMENT WITH ERBITUX (CETUXIMAB) OR WITH VECTIBIX (PANITUMUMAB) MAY BE INDICATED BASED ON A NO MUTATION DETECTED RESULT.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.