Praxis Extended RAS Panel

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Premarket Approval P160038

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.

Pre-market Approval Supplement Details

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.

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
ApplicantIllumina, Inc.
Date Received2016-09-02
Decision Date2017-06-29
Notice Date2017-06-30
PMAP160038
SupplementS
Product CodePQP
Docket Number17M-3983
Advisory CommitteePathology
Expedited ReviewYes
Combination Product No
Applicant Address Illumina, Inc. 5200 Illumina Way san Diego, CA 92122
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160038Original Filing
S024 2022-12-22 30-day Notice
S023 2022-08-18 30-day Notice
S022 2022-06-13 30-day Notice
S021 2022-02-28 30-day Notice
S020 2021-04-12 30-day Notice
S019
S018 2020-11-09 30-day Notice
S017 2020-08-04 30-day Notice
S016 2020-04-06 30-day Notice
S015 2020-01-16 30-day Notice
S014 2019-10-29 30-day Notice
S013 2019-07-31 30-day Notice
S012 2019-04-24 30-day Notice
S011
S010 2019-03-06 30-day Notice
S009 2019-02-15 30-day Notice
S008 2019-02-15 30-day Notice
S007 2018-12-10 30-day Notice
S006 2018-08-24 30-day Notice
S005 2018-08-06 30-day Notice
S004 2018-06-01 30-day Notice
S003 2018-04-04 30-day Notice
S002 2018-03-05 Special (immediate Track)
S001 2018-03-01 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00816270020088 P160038 000

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