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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
PMA NumberP100027
Date Received07/12/2010
Decision Date06/14/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Docket Number 11M-0472
Notice Date 06/15/2011
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023