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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBD DIAGNOSTICS
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP950009
Supplement NumberS002
Date Received06/06/1996
Decision Date05/05/1998
Product Code MNM 
Docket Number 98M-0521
Notice Date 08/12/1998
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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