This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: ThinPrep™ Imaging System
Manufacturer: Cytyc Corporation
Address: 85 Swanson Road, Boxborough, MA 01710
Approval Date: June 6, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020002a.pdf
What is it? The ThinPrep™ Imaging System is a device that uses computer-aided imaging with an automated microscope to screen ThinPrep™ Pap Test slides for cervical cancer or its precursor lesions.
How does it work? The computer-aided imaging processor scans the entire microscope slide and identifies 22 fields of view containing the cells that are most likely to be diagnostically relevant. A cytotechnologist (technician who examines and identifies cellular abnormalities) then uses the automated microscope to identify any abnormal cells in these 22 fields. If there are none, the slide is considered negative and no further review is necessary. If abnormal cells are found, the cytotechnologist reviews the entire slide.
When is it used? The device is used for screening for cervical cancer and can be used for all women who undergo a ThinPrep™ Pap Test.
What will it accomplish? Using this device saves time and labor. A clinical study has shown that using the ThinPrep™ Imaging System to review slides produces as accurate diagnostic results as reviewing slides by manual microscopy.
Additional information: Summary of Safety and Effectiveness and labeling will be available at:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020002