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BD FocalPoint™
Slide Profiler |
INTENDED USE
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The BD FocalPoint™ Slide Profiler is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slides. The BD FocalPoint™ Slide Profiler identifies up to 25% of successfully processed slides as requiring no further review. The BD FocalPoint™ Slide Profiler also identifies at least 15% of all successfully processed slides for a second manual review.
The device is intended to be used on both conventionally-prepared and BD SurePath™ Pap test (formerly AutoCyte™PREP) cervical cytology slides. For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as high risk.
Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.
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