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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: ThinPrep Integrated Imager
PMA Applicant: Hologic, Inc.
Address: 250 Campus Drive, Marlborough, MA 01752
Approval Date: April 18, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf/P950039S036a.pdf
What is it? The ThinPrep Integrated Imager is a computer-based, bench-top device which combines the functions of slide imaging and review into a single system. It is intended to assist in primary cervical cancer screening for the presence of abnormal cells in cervical samples prepared, stained and coverslipped on glass slides which are called ThinPrep Pap test slides.
How does it work? A ThinPrep Pap test slide is loaded on the microscope, and then the ThinPrep Integrated Imager automatically captures images of the cells on the slide. After imaging, the system software finds 22 fields of view that are most likely to contain abnormal cells. The ThinPrep Imager will move the slide to each field of view for a cytotechnologist (a trained medical technologist who interprets cells to detect cancer and other abnormalities under a microscope) to examine the cells under the microscope. If any abnormal cells are found in any of the computer-selected fields, the entire slide is then reviewed by the cytotechnologist. Once the cytotechnologist identifies any abnormal cells, the slide is referred to a cytopathologist (a pathologist trained in the diagnosis of disease by examining cells under a microscope) for further examination under the microscope. After review, a diagnosis of presence or absence of abnormal cells is made.
When is it used? ThinPrep Integrated Imager is used by cytology professionals to assist with primary cervical cancer screening.
What will it accomplish? ThinPrep Integrated Imager helps to detect the presence of abnormal cells from cervical specimens for early detection of cervical cancer.
When should it not be used? There are no known contraindications.
Additional information (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness Data (SSED) and labeling are available online.