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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.
Product CodeNYI
Regulation Number 866.6040
Device Class 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Agendia Inc II Apr-12-2010

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