|Trade Name||PREPSTAIN SYSTEM|
|Classification Name||processor, cervical cytology slide, automated|
|Generic Name||cervical cytology slide preparation device|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification to the surepath slide preparation method which will be marketed under the trade name prepstain system and is indicated for use as a liquid-based thin layer cell preparation process. The prestain system produces surepath slides that are intended as replacements for conventional gynecologic pap smears. Surepath slides are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the bethesda system for reporting cervical/vaginal cytologic diagnoses.