Identity
- Trade Name
- INSITE HER-2/NEU KIT FDA PMA
- Generic Name
- SYSTEM, TEST, HER-2/NEU, IHC FDA PMA
Identifiers
- PMA Number
- P040030 FDA PMA
- FDA Product Code
- MVC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APWD FDA PMA
The Insite HER-2/Neu Kit is an in vitro diagnostic system for immunohistochemistry (IHC) assays. It is designed to semi-quantitatively localize HER-2/neu (c-ERBB-2) protein overexpression in formalin-fixed, paraffin-embedded tissue sections using light microscopy. This aids in assessing breast cancer patients for potential trastuzumab (Herceptin) therapy by evaluating immunostaining results.
The kit is supplied as a reagent system for laboratory use and requires qualification by a pathologist. It is intended for single-use per assay and must be handled under controlled conditions to maintain sterility. The device holds FDA PMA authorization (PMA P040030) and is classified as a Class III medical device. No specific MRI safety or reuse instructions are noted in the regulatory data.
Frequently asked questions
What is the primary clinical purpose of the INSITE HER-2/NEU Kit in breast cancer patient assessment?
The INSITE HER-2/NEU Kit is designed to semi-quantitatively detect HER-2/neu (c-ERBB-2) protein overexpression in formalin-fixed, paraffin-embedded tissue sections using immunohistochemistry (IHC). This aids pathologists in evaluating whether breast cancer patients may benefit from trastuzumab (Herceptin) therapy by assessing immunostaining results. Interpretation requires a qualified pathologist and must be combined with clinical history and other diagnostic findings.
How is the INSITE HER-2/NEU Kit supplied, and is it intended for single-use?
The kit is supplied as a reagent system for laboratory use and is explicitly intended for single-use per assay. Each use requires a new kit to maintain sterility and accuracy, as reuse is not supported by the manufacturer or regulatory data.
Does the INSITE HER-2/NEU Kit require any special handling or storage conditions?
Yes, the kit must be handled under controlled conditions to preserve sterility, though specific storage instructions (e.g., temperature or humidity) are not detailed in the regulatory data. Since it is single-use, it should be stored according to standard laboratory protocols for reagent systems until use.
What regulatory pathway was followed for the INSITE HER-2/NEU Kit’s approval, and what class does it belong to?
The kit holds FDA PMA (Premarket Approval) authorization under PMA number P040030 and is classified as a Class III medical device. PMA approval is required for devices deemed to present a potential risk of illness or injury, necessitating a thorough review of clinical data.
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 | P040030 | Class III | Active |
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Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA PMA P040030 24 fields · synced Sep 18, 2026