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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 NameFOCALPOINT SYSTEMCREENING SYSTEM
Classification Namereader, cervical cytology slide, automated
Generic Namecervical cytology device
ApplicantTRIPATH IMAGING
PMA NumberP950009
Supplement NumberS005
Date Received10/26/2001
Decision Date11/02/2001
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for name changes from autpap primary screening system and autopap system to focalpoint system. The device, as modified, will be marketed under the trade name focalpoint system. The focalpoint system (autopap primary screening system) is indicated for: the focalpoint system is an automated cervicel cytology screening device intended for use in initial screening of cervical cytology clides. The focalpoint system identifies up to 25% of successfully processed slides as requiring no further review. The focalpoint system also identifies at least 15% of all successfully processed slides for a second manual review. The device is intended to be used on both conventionally-prepared and prepstain system cervical cytology slides. For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarconoma 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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