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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Generic Namesystem, test, her-2/neu, nucleic acid or serum
1910 east innovation park dr.
tucson, AZ 85755
PMA NumberP940004
Date Received02/14/1994
Decision Date12/30/1997
Withdrawal Date 10/22/2007
Product Code MVD 
Docket Number 98M-0712
Notice Date 09/09/1998
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Oncor(R) Inform(TM) HER-2/neu Gene Detection System. The Oncor(R) INFORM(TM) HER-2/neu Gene Detection System is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of HER-2/neu gene amplification on formalin-fixed, paraffin-embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priary, invasive, localized breast carcinoma and who are lymph node-negative.
Supplements:  S001