| 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. |
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| Device | INFORM HER2 Dual ISH DNA Probe Cocktail assays |
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| Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
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| Applicant | VENTANA MEDICAL SYSTEMS, INC.
1910 E. Innovation Park Dr.
Tucson, AZ 85755 |
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| PMA Number | P100027 |
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| Supplement Number | S030 |
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| Date Received | 02/13/2019 |
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| Decision Date | 05/03/2019 |
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| Product Code |
NYQ |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT01772472
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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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. |
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