Oncor AmpliTect HER/NEU(ERBB2) Gene Amplification System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI FDA PMA
- Generic Name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM FDA PMA
Identifiers
- PMA Number
- P940004 FDA PMA
- FDA Product Code
- MVD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APWD FDA PMA
The Oncor AmpliTect HER/NEU(ERBB2) Gene Amplification System is a fluorescence in situ hybridization (FISH) DNA probe assay designed to detect qualitative HER-2/neu gene amplification in formalin-fixed, paraffin-embedded human breast tissue. It serves as an adjunct to clinical and pathologic assessments for stratifying breast cancer patients based on recurrence risk or disease-related mortality.
This system is intended for use in pathology laboratories and requires formalin-fixed, paraffin-embedded tissue samples from patients with primary, invasive, localized breast carcinoma who are lymph node-negative. It is supplied as a Class III medical device with an FDA Premarket Approval (PMA) under PMA number P940004, adhering to regulatory standards for diagnostic testing. The assay is not reusable and must be handled in accordance with standard laboratory protocols for nucleic acid testing.
Frequently asked questions
What types of breast cancer patients is this assay designed to help evaluate, and why is it used alongside other tests?
This assay is designed for patients with **primary, invasive, localized breast carcinoma who are lymph node-negative**, meaning their cancer has not spread to nearby lymph nodes. It detects **HER-2/neu gene amplification** in formalin-fixed, paraffin-embedded tissue samples to serve as an **adjunct to clinical and pathologic assessments**, helping stratify patients by recurrence risk or disease-related mortality. Since it provides molecular insights, it complements traditional pathology and clinical evaluations rather than replacing them.
Is this system reusable, and how should it be handled in a laboratory setting?
No, the Oncor AmpliTect HER/NEU(ERBB2) Gene Amplification System is **not reusable**. It is intended for **single-use** in pathology laboratories and must be handled according to standard **nucleic acid testing protocols**, including proper sterilization and disposal procedures to ensure accuracy and safety.
What kind of tissue samples does this assay require, and why is formalin fixation important?
The assay requires **formalin-fixed, paraffin-embedded (FFPE) human breast tissue samples** from patients with the specified cancer type. Formalin fixation is critical because it preserves the tissue structure and DNA integrity over time, allowing reliable detection of HER-2/neu gene amplification—a key factor in its use as a prognostic tool.
How is this device regulated, and what does its FDA Premarket Approval (PMA) status mean for users?
This device holds an **FDA Premarket Approval (PMA) under PMA number P940004**, classifying it as a **Class III medical device**. This means it has undergone rigorous review to ensure its safety and effectiveness for detecting HER-2/neu gene amplification in breast cancer patients, providing users with confidence in its regulatory compliance and clinical utility.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P940004 | Class III | Active |
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Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P940004 24 fields · synced Oct 6, 2026