Identity
- Trade Name
- PATHVYSION HER-2 DNA PROBE KIT FDA PMA
- Generic Name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM FDA PMA
Identifiers
- PMA Number
- P980024 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 PathVysion HER-2 DNA Probe Kit is a system test designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded human breast cancer tissue specimens. It is intended as an adjunct to existing clinical and pathologic information for prognostic use in stage II, node-positive breast cancer patients.
The kit is supplied for use in pathology laboratories and is indicated to aid in predicting disease-free and overall survival in patients with stage II, node-positive breast cancer treated with adjuvant CAF chemotherapy. It has received FDA PMA authorization (P980024) and is classified as a Class III device under product code MVD.
Frequently asked questions
What type of specimen is required for the PathVysion HER-2 DNA Probe Kit?
The kit requires formalin-fixed paraffin-embedded human breast cancer tissue specimens, as specified in the device's approval statement for FISH-based detection of HER-2/neu gene amplification.
Is the PathVysion HER-2 DNA Probe Kit intended for use in all breast cancer patients?
No, the kit is specifically indicated as an adjunct to clinical and pathologic information for prognostic use in stage II, node-positive breast cancer patients, not for all breast cancer cases.
What chemotherapy regimen is associated with the prognostic use of the PathVysion HER-2 DNA Probe Kit?
The kit is intended to aid in predicting disease-free and overall survival in patients with stage II, node-positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy.
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 | P980024 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P980024 24 fields · synced Sep 18, 2026