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.