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. |
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Device | Praxis Extended RAS Panel |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Illumina, Inc. 5200 ILLUMINA WAY SAN DIEGO, CA 92122 |
PMA Number | P160038 |
Date Received | 09/02/2016 |
Decision Date | 06/29/2017 |
Withdrawal Date
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12/22/2023 |
Product Code |
PQP |
Docket Number | 17M-3983 |
Notice Date | 06/30/2017 |
Advisory Committee |
Pathology |
Clinical Trials | NCT00364013
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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
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 |
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