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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBD FOCALPOINT GS IMAGING SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBD DIAGNOSTICS
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP950009
Supplement NumberS008
Date Received10/02/2007
Decision Date12/03/2008
Product Code MNM 
Docket Number 09M-0016
Notice Date 01/27/2009
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FORTHE BD FOCALPOINT GS IMAGING SYSTEM. THIS DEVICE IS INDICATED TO ASSIST IN CERVICAL CANCERSCREENING OF BD SUREPATH PAP TEST SLIDES TO DETECT EVIDENCE OF SQUAMOUS CARCINOMA,ADENOCARCINOMA, AND THEIR USUAL PRECURSOR CONDITIONS. THESE SLIDES WILL BE RANKED ACCORDING TOTHE LIKELIHOOD OF ABNORMALITY, AND PROVIDE RELOCATION AND VISUAL REVIEW OF UP TO 10 FIELDS OF VIEW(FOVS) MOST LIKELY TO CONTAIN ABNORMAL CELLS. ADDITIONALLY, THE SYSTEM IDENTIFIES AT LEAST 15% OFALL SUCCESSFULLY PROCESSED SLIDES WITH THE BD FOCAL POINT SLIDE PROFILER* DIRECTED QCTECHNOLOGY FOR A DIRECTED QC RE-SCREEN. INTENDED USERS ARE TRAINED CYTOLOGY LABORATORYPERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORYMANAGER/DIRECTOR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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