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: MonoPrep Pap Test
PMA Applicant: MonoGen, Inc.
Address: 1033 Butterfield Road, Vernon Hills, IL 60061
Approval Date: March 3, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040052a.pdf
What is it? The MonoPrep Pap Test (MPPT) system is a device used to collect and prepare cell samples from a female patient’s cervix for Pap stain-based screening for cervical cancer, its precursor lesions and other cytologic categories and conditions.
How does it work?
- A cervical specimen is collected from a female patient and the cells are rinsed into a vial containing the collection fluid.
- The vial is sent to the laboratory where the MPPT Processor automatically estimates the concentration of cells in the vial and calculates the time needed to filter and deposit the target number of cells on the microscope slide.
- The slide is then fixed, stained, and manually reviewed by a trained cytotechnologist and cytopathologist who use a microscope to screen the slide for the presence of abnormal cells.
When is it used? The MPPT system can be used for all women who are screened for cervical cancer or its precursor lesions.
What will it accomplish? Results from the clinical trial demonstrate the MPPT system is safe and effective for preparing gynecological slides to screen for cervical abnormalities.
When should it not be used? There are no known contraindications for this device.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040052