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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 PRIMARY SCREENING SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBd Diagnostics
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP950009
Supplement NumberS004
Date Received10/01/1999
Decision Date10/05/2001
Product Code MNM 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR USE OF THE DEVICE WITH AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AUTOPAP PRIMARY SCREENING SYSTEM AND IS INDICATED FOR: THE AUTOPAP PRIMARY SCREENING SYSTEM IS AN AUTOMATED CERVICAL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY SLIDES. THE AUTOPAP PRIMARY SCREENING SYSTEM IDENTIFIES UP TO 25% OF SUCCESSFULLY PROCESSED SLIDES AS REQUIRING NO FURTHER REVIEW. THE AUTOPAP PRIMARY SCREENING SYSTEM ALSO IDENTIFIES AT LEASE 15% OF ALL SUCCESSFULLY PROCESSED SLIDES FOR A SECOND MANUAL REVIEW. THE DEVICE IS INTENDED TO BE USED ON BOTH CONVENTIONALLY-PREPARED AND AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES. FOR BOTH PREPARATION METHODS, THE DEVICE 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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