Identity
- Trade Name
- UROVYSION BLADDER CANCER KIT FDA PMA
Identifiers
- PMA Number
- P030052 FDA PMA
Classification
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The UroVysion Bladder Cancer Kit is an in vitro diagnostic device classified as a fluorescence in situ hybridization (FISH) assay. It is designed to detect chromosomal aneuploidy for chromosomes 3, 7, and 17, as well as loss of the 9p21 locus in urine specimens, aiding in the evaluation of bladder cancer risk in patients with hematuria.
This kit is intended for use in clinical pathology laboratories and is supplied as a single-use diagnostic tool. It requires specialized equipment for fluorescence microscopy and is approved for use in conjunction with standard diagnostic procedures, not as a replacement. The device is regulated under an FDA Premarket Approval (PMA) and is not intended for MRI or other imaging environments.
Frequently asked questions
What specific chromosomal abnormalities does the UroVysion Bladder Cancer Kit detect in urine samples?
The UroVysion Bladder Cancer Kit detects chromosomal aneuploidy for chromosomes 3, 7, and 17, as well as loss of the 9p21 locus in urine specimens. These genetic markers are associated with bladder cancer risk and help evaluate whether hematuria (blood in urine) may be due to bladder carcinoma.
Is the UroVysion Bladder Cancer Kit intended for use in all clinical settings, or does it require specialized equipment?
The kit is designed for use *only* in clinical pathology laboratories that have specialized equipment for fluorescence microscopy. It is not intended for point-of-care or non-laboratory settings, nor is it meant to replace standard diagnostic procedures—it is used *in conjunction* with them for bladder cancer evaluation.
How is the UroVysion Bladder Cancer Kit supplied, and is it reusable?
The kit is supplied as a **single-use** diagnostic tool, meaning each kit is intended for one test cycle only. It is not designed for reuse or reprocessing, ensuring consistency and sterility for accurate results.
What patient population is the UroVysion Bladder Cancer Kit intended to aid in diagnosing?
The kit is specifically intended for patients with **hematuria** (visible or microscopic blood in urine) who are suspected of having bladder cancer. It aids in the initial diagnosis of bladder carcinoma and subsequent monitoring for tumor recurrence in patients already diagnosed with bladder cancer.
What regulatory pathway was followed for the UroVysion Bladder Cancer Kit, and what does that mean for its use?
The kit was approved through the **FDA Premarket Approval (PMA)** process, which requires rigorous clinical evidence demonstrating safety and effectiveness. This means its use is strictly governed by the approved indications—detecting chromosomal abnormalities in urine for bladder cancer evaluation—and must be performed in compliance with FDA-mandated labeling and laboratory protocols.
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. Sources consulted: UroVysion Bladder Cancer Kit | Abbott Molecular, UroVysion Bladder Cancer Kit | Abbott Molecular, UroVysion - DSS Image
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P030052 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA PMA P030052 24 fields · synced Sep 18, 2026