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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NamePLEXIMMUNE ASSAY
Classification Nametest, cell mediated immune response, liver and small bowel transplant/transplantation
Generic Nametest, cell mediated immune response, liver and small bowel transplant/transplantation
Applicant
PLEXISION INC.
4424 penn avenue
suite 202 medical building
pittsburg, PA 15224
HDE NumberH130004
Date Received08/13/2013
Decision Date08/26/2014
Product Code
PHK[ Registered Establishments with PHK ]
Docket Number 14M-1280
Notice Date 09/10/2014
Advisory Committee Clinical Chemistry
Clinical Trials NCT01163578
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval forpleximmune¿. This device is indicated for: the pleximmune¿ test is intended to be performed at a single laboratory to measure the cd154expression on t-cytotoxic memory cells (tcm) in patient¿s peripheral blood lymphocytes (pbl) isolated from heparinized whole blood (anticoagulant ¿ sodium heparin). The pleximmune¿ test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The pleximmune¿ test is an aid in the evaluation of the risk of acute cellular rejection (acr) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information. The pleximmune¿ test is intended for use at the following time periods:1) pre-transplantation period: for blood samples collected before transplantation, the test predicts the risk of transplant rejection within 60 days after transplantation;2) early and late post-transplantation period: for blood samples collected within 60 days (early) after transplantation and for blood samples collected at 200 or more days (late) after transplantation, the test predicts the risk of transplant rejection within 60 days after sampling.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
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