Identity
- Trade Name
- DAKO HERCEPTEST FDA PMA
- Generic Name
- SYSTEM, TEST, HER-2/NEU, IHC FDA PMA
Identifiers
- PMA Number
- P980018 FDA PMA
- FDA Product Code
- MVC FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The DAKO HercepTest is a semi-quantitative immunohistochemical assay designed to detect HER2 overexpression in breast cancer tissues. It is classified as a System, Test, HER-2/NEU, IHC device and is intended for use in routine histological evaluation of tissue samples.
This assay is supplied as a diagnostic test for use in pathology laboratories and is approved for determining HER2 status in patients under consideration for Herceptin (Trastuzumab) treatment. The device is regulated under FDA PMA (P980018) and is classified as a Class III medical device. It is intended for single-use and requires proper storage and handling as specified in the accompanying instructions.
Frequently asked questions
What is the primary clinical purpose of the DAKO HercepTest, and how does it assist in patient care?
The DAKO HercepTest is a semi-quantitative immunohistochemical assay used to detect HER2 overexpression in breast cancer tissues. It aids in determining HER2 status, which helps clinicians assess whether a patient may benefit from Herceptin (Trastuzumab) treatment. This is critical for guiding personalized therapy decisions in breast cancer care.
Is the DAKO HercepTest intended for reuse, or is it designed for single-use only?
The DAKO HercepTest is explicitly intended for single-use only. This is standard for diagnostic assays to ensure accuracy and prevent cross-contamination, as outlined in the accompanying instructions for storage and handling.
What type of laboratory setting is this test designed for, and what are its key specifications?
The DAKO HercepTest is designed for use in pathology laboratories, where routine histological evaluation of tissue samples occurs. It is classified as a **System, Test, HER-2/NEU, IHC** device under FDA PMA (P980018) and is a **Class III** medical device. The test is semi-quantitative, meaning it provides a relative measure of HER2 expression rather than an absolute value.
How should the DAKO HercepTest be stored, and are there any special handling requirements?
While the exact storage conditions are detailed in the accompanying instructions, the DAKO HercepTest—like most single-use diagnostic assays—requires proper storage to maintain its integrity. This typically includes protection from extreme temperatures, moisture, and light, as well as adherence to expiration dates. Always follow the manufacturer’s guidelines to ensure reliable performance.
What regulatory pathway was followed for the approval of the DAKO HercepTest, and what does this mean for its use?
The DAKO HercepTest was approved through the FDA’s **Premarket Approval (PMA)** process under PMA number **P980018**, which is the highest level of regulatory review for high-risk medical devices like Class III products. This approval confirms that the device meets stringent safety and effectiveness standards for detecting HER2 overexpression in breast cancer tissues, ensuring its reliability for clinical decision-making.
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 | P980018 | Class III | Active |
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Manufacturer
- FDA Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
Sources (1)
- FDA PMA P980018 24 fields · synced Oct 6, 2026