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: BD FocalPoint™ GS Imaging System
PMA Applicant: BD Diagnostics, Diagnostic Systems, TriPath
Address:4025 Stirrup Creek Drive , Durham, NC 27703
Approval Date: December 3, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p950009s008a.pdf
What is it? The BD FocalPoint™ GS Imaging System is a computer-aided imaging instrument equipped with an automated microscope for scanning specific test slides, BD SurePath™ Pap Test slides. The System is used for initial screening for abnormal cells in cervical cytology samples.
How does it work? The FocalPoint™ GS Imaging System scans the slide identifying up to 10 fields of view most likely to contain abnormal cells. The cytotechnologist uses the review microscope to identify any abnormal cells in these 10 fields. If there are no abnormal cells among all 10 fields of view, the slide is considered negative and no further review is necessary. If abnormal cells are found, the whole slide is reviewed.
When is it used?The patient population consists of all women who are being screened for cervical cancer using the BD SurePath™ Pap Test.
What will it accomplish? The FocalPoint™ GS Imaging System could save time and labor in the review of cervical cytology samples in addition to providing equivalent or more accurate diagnoses when compared to manual microscopy as demonstrated by the clinical study.
When should it not be used? The FocalPoint™ GS Imaging System can only be used with SurePath™ Pap Test slides.
Additional information: The Summary of Safety and Effectiveness will be available online.