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U.S. Department of Health and Human Services

Medical Devices

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Vysis® AutoVysion™ System - K041875

This is a brief overview of information related to FDA’s clearance to market this product. 


Product Name: Vysis® AutoVysion™ System
Manufacturer: Vysis, Inc.
Address: 3100 Woodcreek Dr. , Downers Grove , IL 60515
Clearance Date: December 13, 2004
Clearance Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041875.pdf

What is it?

The Vysis® AutoVysion™ System is an automated system that is used to analyze human tissue samples attached to microscope slides. The system consists of:

  • a fluorescence microscope with a motorized scanning stage
  • a black and white (monochrome) CCD camera
  • a computer
  • software programs designed to identify and count specific genes that are “painted” with fluorescent dyes in DNA probe kits (Fluorescence in situ Hybridization (FISH) kits)

How does it work?

  • A patient tissue section is placed on a microscope slide and treated with a specific fluorescence labeled DNA probe.
  • Fluorescence labeled DNA probes mark the candidate cells.
  • The labeled sample is placed under the microscope and examined by a medical professional who checks the quality of the fluorescence signals and records the areas for analysis.
  • The Vysis® AutoVysion™ System captures the fluorescent images of the marked areas and saves the images in the computer.
  • The Vysis® AutoVysion™ System counts the fluorescent signals in each area and presents the results to a medical professional.
  • The medical professional rechecks the results generated by the Vysis® AutoVysion™ System and reports results.

 When is it used?

The Vysis® AutoVysion ä System is used when identification and counting of fluorescent signals on cells are required by a specific fluorescent in situ hybridization (FISH) assay.  

What will it accomplish?

The Vysis® AutoVysion ä System could standardize and improve the counting of fluorescence signals in FISH assays. The System could also reduce hands-on time used for manual counting by a medical professional.  

When should it not be used? There are no contraindications for this device.