Identity
- Trade Name
- VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK FDA PMA
- Generic Name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement FDA PMA
Identifiers
- PMA Number
- P110012 FDA PMA
- FDA Product Code
- OWE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Vysis ALK Break Apart FISH Probe Kit is a qualitative fluorescence in situ hybridization (FISH) test designed to detect rearrangements involving the anaplastic lymphoma kinase (ALK) gene in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It aids in identifying patients eligible for targeted therapy with ALK inhibitors, such as crizotinib.
This kit is intended for use in pathology laboratories and requires preparation of FFPE NSCLC tissue sections on positively charged slides. It includes components for pretreatment, hybridization, and post-hybridization washing, along with control slides for assay validation. The device is approved by the FDA under PMA number P110012 and is classified as a Class III medical device. It is supplied as a single-use diagnostic kit and must be handled according to standard laboratory protocols for FISH testing.
Frequently asked questions
What specific type of lung cancer tissue samples is this kit designed to analyze, and why is this important for patient care?
The Vysis ALK Break Apart FISH Probe Kit is designed exclusively for formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. This specificity is critical because it helps identify patients with NSCLC who have ALK gene rearrangements, making them eligible for targeted therapy with ALK inhibitors like crizotinib (XALKORI). Detecting these rearrangements through FISH testing ensures clinicians can personalize treatment plans for patients who may benefit most from these therapies.
Is this kit intended for single-use only, and if so, what does that mean for laboratory workflows?
Yes, the Vysis ALK Break Apart FISH Probe Kit is supplied as a single-use diagnostic kit. This means each kit is designed for one test run and should not be reused, ensuring accuracy and consistency in results. Laboratories must account for this in their workflows by ordering the appropriate quantity of kits based on their testing volume and ensuring proper inventory management to avoid shortages or waste.
What components are included in the kit to ensure accurate testing, and how are they used in the workflow?
The kit includes components for pretreatment, hybridization, and post-hybridization washing of FFPE NSCLC tissue sections on positively charged slides, along with two types of control slides: ProbeChek ALK Negative and ProbeChek ALK Positive. The negative control slides verify appropriate hybridization conditions, while the positive control slides confirm the assay’s functionality. These controls must be assayed alongside patient specimens as per the package insert to validate the test’s reliability and accuracy.
How does the kit’s regulatory approval impact its use in clinical settings, particularly regarding patient eligibility for ALK inhibitor therapy?
The kit is approved by the FDA under PMA number P110012, confirming its safety, effectiveness, and compliance with regulatory standards for Class III medical devices. This approval directly supports clinical decision-making by validating its use in identifying ALK gene rearrangements in NSCLC patients, which aids in determining eligibility for ALK inhibitor therapies like crizotinib. Clinicians can rely on this approval to ensure the test’s results are actionable for targeted treatment planning.
What type of laboratory setup is required to use this kit, and are there any specific handling instructions to note?
The kit is intended for use in pathology laboratories equipped for fluorescence in situ hybridization (FISH) testing. It requires preparation of FFPE NSCLC tissue sections on positively charged slides, adherence to standard laboratory protocols for FISH, and careful handling of the single-use components. Laboratories must follow the included package insert instructions meticulously, particularly regarding pretreatment, hybridization, and washing steps, to ensure accurate and reproducible results.
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: Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, PDF Vysis ALK Break Apart FISH Probe Kit en - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110012 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P110012 24 fields · synced Sep 18, 2026