Identity
- Trade Name
- DAKOCYTOMATION HER2 FISH PHARMDX KIT FDA PMA
- Generic Name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM FDA PMA
Identifiers
- PMA Number
- P040005 FDA PMA
- FDA Product Code
- MVD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The DAKOcytomation HER2 FISH PharMDx Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively assess HER2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue specimens. This diagnostic tool aids in evaluating patient eligibility for HERCEPTIN (trastuzumab) treatment by providing adjunctive molecular data alongside standard clinicopathologic assessments.
This kit is supplied as a single-use diagnostic reagent intended for use in pathology laboratories. It requires formal preparation of tissue samples and is not MRI-compatible. The device is authorized under FDA PMA (P040005) and is classified as a Class III medical device (OpenFDA: MVD, device_class=3). Storage and handling must comply with manufacturer guidelines for nucleic acid-based assays to ensure assay integrity.
Frequently asked questions
What is the primary clinical purpose of the DAKOcytomation HER2 FISH PharMDx Kit, and how does it support treatment decisions for breast cancer patients?
The DAKOcytomation HER2 FISH PharMDx Kit is a direct fluorescence in situ hybridization (FISH) assay designed to quantitatively assess HER2 gene amplification in formalin-fixed, paraffin-embedded breast cancer tissue specimens. It aids clinicians in evaluating whether patients may benefit from HERCEPTIN (trastuzumab) treatment by providing molecular data alongside standard clinicopathologic assessments. This is particularly useful for patients with stage II, node-positive breast cancer, where HER2 status helps guide prognosis and targeted therapy decisions.
Is the DAKOcytomation HER2 FISH PharMDx Kit intended for single-use or repeated use, and what type of laboratory setting is it designed for?
The kit is explicitly supplied as a single-use diagnostic reagent and is intended for use in pathology laboratories. It requires formal preparation of tissue samples and is not designed for repeated use or in MRI-compatible environments. Its single-use nature ensures consistency and reliability for each test run.
What regulatory pathway was followed for the approval of this device, and what classification does it hold under FDA regulations?
The DAKOcytomation HER2 FISH PharMDx Kit was authorized through the FDA Premarket Approval (PMA) pathway, with the approval number P040005. It is classified as a Class III medical device, reflecting its role in diagnosing HER2 gene amplification—a critical factor in breast cancer treatment decisions. This classification requires rigorous pre-market approval due to its high-risk nature.
How should the kit be stored, and are there any special handling requirements to maintain its integrity?
While the exact storage instructions are manufacturer-specific, the kit must comply with guidelines for nucleic acid-based assays to preserve assay integrity. Proper storage conditions—such as temperature, humidity, and light exposure—are critical to maintaining the stability of reagents. Always follow the manufacturer’s instructions to ensure accurate and reliable test results.
Does this kit provide results that can be used independently of other clinicopathologic assessments, or is it meant to complement existing diagnostic methods?
The results from the DAKOcytomation HER2 FISH PharMDx Kit are intended as an adjunct to standard clinicopathologic information used for estimating prognosis in breast cancer patients. They are not meant to replace existing diagnostic methods but rather provide additional molecular data to support treatment decisions, particularly for HERCEPTIN eligibility.
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 | P040005 | Class III | Active |
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Manufacturer
- FDA Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
Sources (1)
- FDA PMA P040005 24 fields · synced Oct 6, 2026