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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Classification Namereader, cervical cytology slide, automated
Generic Namecervical cytology device
ApplicantNEOPATH, INC.
PMA NumberP950009
Supplement NumberS002
Date Received06/06/1996
Decision Date05/05/1998
Product Code
MNM[ Registered Establishments with MNM ]
Docket Number 98M-0521
Notice Date 08/12/1998
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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