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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePraxis Extended RAS Panel
Classification Namenext generation sequencing oncology panel, somatic or germline variant detection system
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
Illumina, Inc.
5200 illumina way
san diego, CA 92122
PMA NumberP160038
Date Received09/02/2016
Decision Date06/29/2017
Product Code
PQP[ Registered Establishments with PQP ]
Docket Number 17M-3983
Notice Date 06/30/2017
Advisory Committee Pathology
Clinical Trials NCT00364013
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the Praxis Extended RAS Panel is a qualitative in vitro diagnostic test using targeted high throughput parallel sequencing for the detection of 56 specific mutations in RAS genes [KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4)] in DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The Praxis™ Extended RAS Panel is indicated to aid in the identification of patients with colorectal cancer for treatment with Vectibix® (panitumumab) based on a no mutation detected test result. The test is intended to be used on the Illumina MiSeqDx® instrument.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 
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