|Trade Name||AUTOPAP SYSTEM|
|Classification Name||reader, cervical cytology slide, automated|
|Generic Name||reader, cervical cytology slide, automated|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for removal of the stage three-alarm unit. The device is to be used only on conventionally prepared pap smear slides and 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.