- Device
- FOCALPOINT SYSTEMCREENING SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S005
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2001-11-02
- Decision code
- APPR
- Date received
- 2001-10-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.