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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceINFORM HER2 Dual ISH DNA Probe Cocktail assays
Generic NameChromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP100027
Supplement NumberS030
Date Received02/13/2019
Decision Date05/03/2019
Product Code NYQ 
Advisory Committee Pathology
Clinical TrialsNCT01772472
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the Ventana Medical Systems, Inc’s (Ventana) INFORM HER2 Dual ISH DNA Probe Cocktail is intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected by light microscopy using two color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on a BenchMark XT or BenchMark ULTRA instrument. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine) 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.