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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.
 
DeviceINFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP100027
Date Received07/12/2010
Decision Date06/14/2011
Product Code NYQ 
Docket Number 11M-0472
Notice Date 06/15/2011
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL. THIS DEVICE IS INDICATED FOR:THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INTENDED FOR USE IN DETERMINING HER2 GENE STATUS BY ENUMERATION OF THE RATIO OF THE HER2 GENE TO CHROMOSOME 17. THE HER2 AND CHROMOSOME 17 PROBES ARE DETECTED USING TWO COLOR CHROMOGENIC IN SITU HYBRIDIZATION (ISH) IN FORMALIN-FIXED. PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS FOLLOWING STAINING ON VENTANA BENCHMARK XT AUTOMATED SLIDE STAINERS (USING NEXES SOFTWARE), BY LIGHT MICROSCOPY. THE INFORM HER2 DUAL ISH DNA PROBE COCKTAIL IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM I-HERPCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.THIS PRODUCT SHOULD BE INTERPRETED BY A QUALIFIED READER IN CONJUNCTION WITH HISTOLOGICAL EXAMINATION, RELEVANT CLINICAL INFORMATION, AND PROPER CONTROLS.THIS REAGENT IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 
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