- Device
- AUTOPAP PRIMARY SCREENING SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S004
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2001-10-05
- Decision code
- APPR
- Date received
- 1999-10-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.