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Device | BD FOCALPOINT GS IMAGING SYSTEM |
Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Applicant | BD DIAGNOSTICS 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P950009 |
Supplement Number | S008 |
Date Received | 10/02/2007 |
Decision Date | 12/03/2008 |
Product Code |
MNM |
Docket Number | 09M-0016 |
Notice Date | 01/27/2009 |
Advisory Committee |
Pathology |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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