TOP2A FISH PharMDx Kit
by Dako Denmark A/S Denmark PMA
PMA P050045 Product code NXG
Overview
The Top2A FISH PharMDx Kit is a Fluorescence In Situ Hybridization (FISH) diagnostic device designed to detect copy number changes—specifically amplifications and deletions—of the TOP2A gene. It is intended for use on formalin-fixed, paraffin-embedded human breast cancer tissue specimens, where TOP2A alterations serve as prognostic markers for high-risk patients.
This kit is supplied as a single-use diagnostic tool and is regulated under an FDA Premarket Approval (PMA) with PMA number P050045. It is classified as a Class III device and requires use in a pathology setting, where results are intended to complement existing clinical and pathological assessments. Storage and handling conditions are not specified but must adhere to standard laboratory protocols for FISH assays.
Regulatory status
Withdrawn since 11 Jan 2008. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP050045 | Date11 Jan 2008 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Specification
- Trade Name
- Dako TOP2A Fish Pharmdx Kit
- Generic Name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- PMA Number
- FDA Product Code
- NXG
- Device Class
- Class III
- Advisory Committee
- Pathology
- FDA Decision
- APWD Approval withdrawn
Other devices from Dako Denmark A/S
Questions
What specific type of breast cancer tissue specimens can the TOP2A FISH PharMDx Kit analyze, and why is this important for prognosis?
The kit is designed exclusively for formalin-fixed, paraffin-embedded human breast cancer tissue specimens. This is important because TOP2A gene alterations—detected as amplifications or deletions—serve as prognostic markers for poor outcomes in high-risk breast cancer patients, helping guide clinical decision-making alongside existing assessments.
Is the TOP2A FISH PharMDx Kit intended for single-use or repeated use, and how does this affect workflow in a pathology lab?
The kit is supplied as a single-use diagnostic tool, meaning each kit is intended for one analysis. This ensures consistency and reliability in results while minimizing cross-contamination risks, which is critical in a pathology setting where precision and traceability are essential for patient care.
What regulatory pathway does the TOP2A FISH PharMDx Kit follow, and what does this mean for its use in clinical practice?
The kit follows the FDA Premarket Approval (PMA) pathway, classified as a Class III device (PMA number P050045). This indicates it has undergone rigorous review to ensure safety and effectiveness for detecting TOP2A gene copy number changes in breast cancer specimens, and its use is restricted to qualified pathology labs as an adjunct to clinical and pathological evaluations.
How does the TOP2A FISH PharMDx Kit complement existing clinical assessments for breast cancer patients?
The kit detects TOP2A gene amplifications or deletions via FISH, providing additional molecular insights into tumor biology. These genetic markers are linked to poor prognosis in high-risk breast cancer, allowing clinicians to refine risk stratification and tailor treatment plans—such as chemotherapy decisions—beyond traditional pathological assessments.
Are there any special storage or handling requirements for the TOP2A FISH PharMDx Kit beyond standard laboratory protocols?
While specific storage conditions aren’t detailed, the kit must adhere to standard laboratory protocols for FISH assays, including protection from light, temperature control, and proper containment. Since it’s single-use and intended for pathology settings, maintaining chain-of-custody and avoiding contamination are paramount for accurate results.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P050045