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Inform HER2 Dual ISH DNA Probe Cocktail

FDA PMA

Class III (US FDA PMA)

PMA P100027

by Ventana Medical Systems, Inc.

Identity

Trade Name
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL FDA PMA
Generic Name
Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer FDA PMA

Identifiers

PMA Number
P100027 FDA PMA
FDA Product Code
NYQ FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Pathology FDA PMA
FDA Decision
APWD FDA PMA

The Inform HER2 Dual ISH DNA Probe Cocktail is a Chromogenic In Situ Hybridization (ISH) assay designed for determining HER2 gene status. It quantifies the HER2 gene-to-chromosome 17 ratio in formalin-fixed, paraffin-embedded human breast cancer tissue specimens using dual-color chromogenic detection. This diagnostic tool aids in evaluating patient eligibility for HER2-targeted therapies, such as trastuzumab (I-HERCEPTIN).

This in vitro diagnostic reagent is intended for use on Ventana Benchmark XT automated slide stainers with NEXES software and requires interpretation by a qualified reader alongside histological examination and clinical correlation. Supplied as a single-use probe cocktail, it is classified as a Class III device under FDA regulations (PMA Number: P100027). Sterility and handling instructions are specified in the accompanying documentation.

Frequently asked questions

What clinical question does the INFORM HER2 Dual ISH DNA Probe Cocktail help answer in breast cancer patients?

This probe cocktail determines the HER2 gene-to-chromosome 17 ratio in formalin-fixed, paraffin-embedded breast cancer tissue. It aids clinicians in assessing whether a patient’s tumor exhibits HER2 gene amplification, which is critical for evaluating eligibility for HER2-targeted therapies like trastuzumab (I-HERCEPTIN). Results must be interpreted alongside histological examination and clinical correlation by a qualified reader.

How is the INFORM HER2 Dual ISH DNA Probe Cocktail supplied and intended for use?

The probe cocktail is supplied as a single-use reagent designed exclusively for use on Ventana Benchmark XT automated slide stainers with NEXES software. It requires dual-color chromogenic detection to visualize HER2 and chromosome 17 probes under light microscopy. Sterility and handling instructions are detailed in the accompanying documentation, emphasizing its in vitro diagnostic (IVD) purpose.

Is this device reusable, or is it intended for one-time use per sample?

The INFORM HER2 Dual ISH DNA Probe Cocktail is explicitly labeled as a single-use product. Each vial is intended for one assay run, ensuring consistency and sterility for accurate HER2 gene status determination in formalin-fixed, paraffin-embedded breast tissue specimens.

What regulatory pathway was followed for approval of this device?

This device was approved through the FDA’s Premarket Approval (PMA) process, designated as a Class III medical device. The approval (PMA Number: P100027) confirms its compliance with rigorous standards for in vitro diagnostic reagents used in determining HER2 gene status for breast cancer patient management.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AI systems to optimize business processes - INFORM

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Ventana Medical Systems, Inc.

Sources (1)

  • FDA PMA P100027 24 fields · synced Oct 6, 2026