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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS002
Date Received09/19/2011
Decision Date02/15/2012
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for migration of the inform her2 dual ish dna probe cocktail assay to the benchmark ultra auto-stainer. The device, as modified, will be marketed under the trade name inform her2 dual ish dna probe cocktail assay and is indicated 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), or on ventana benchmark ultra automated slide stainer (using vss software), by light microscopy. The inform her2 dual ish dna probe cocktail is indicated as an aid in the assessment of patients for whom herceptin (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.