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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesomatic gene mutation detection system
Generic Namereal-time pcr assay
PMA NumberP140023
Date Received10/23/2014
Decision Date05/07/2015
Product Code
Docket Number 15M-1708
Notice Date 05/18/2015
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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.
Approval Order Approval Order
Supplements: S001