- Device
- AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S002
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 1998-05-05
- Decision code
- APPR
- Date received
- 1996-06-06
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- The AutoPap(R) Primary Screening System is an automated cervical cytology screening device intended for use in initial screening of Papanicolaou (Pap) smear slides. The AutoPap(R) Primary Screening System identifies up to 25% of successfully processed slides as requiring no further review. The AutoPap(R) Primary Screening System also identifies as least 15% of all successfully processed slides for a second manual review. 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.