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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NameKIT D816V ASSAY
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
ARUP LABARATORIES
500 chipeta way
salt lake city, UT 84108
HDE NumberH140006
Date Received11/26/2014
Decision Date12/18/2015
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 15M-4949
Notice Date 01/14/2016
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for the kit d816v mutation detection by pcr for gleevec eligibility in aggressive systemic mastocytosis (asm). Kit d816v mutation detection by pcr for gleevec eligibility in aggressive systemic mastocytosis (asm) (referred to as the ¿kit d816v assay¿) is an in vitro diagnostic test intended for qualitative polymerase chain reaction (pcr) detection of kit d816v mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis. The kit d816v mutational assay is indicated as an aid in the selection of asm patients for whom gleevec® (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
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