PMA P970018S002

Device: AUTOCYTE PREP SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S002
Product code: MKQ
Decision date: 2001-05-25
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL FOR THE ADDITION OF THE PREPMATE ACCESSORY (PREPMATE METHOD), WHICH AUTOMATES THE INITIAL MANUAL STEPS OF THE AUTOCYTE PREP LABORATORY PROCESS. THE PREPMATE AUTOMATICALLY MIXES AND REMOVES THE SPECIMEN FROM THE GYN PRESERVATIVE VIALS, AND LAYERS THE SPECIMEN ONTO CYTORICH DENSITY REAGENT IN A TEST TUBE, AND FOR THE ADDITION OF THE MANUAL METHOD, IN WHICH, RATHER THAN USING THE AUTOCYTE PREP SYSTEM FOR CELL SUSPENSION AND SLIDE STAINING, THE CELL SUSPENSION IS MANUALLY LAYERED ONTO THE SLIDE AND STAINED BY A LABORATORY TECHNICIAN.

Current openFDA PMA Record#

Device: AUTOCYTE PREP SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S002
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2001-05-25
Decision code: APPR
Date received: 2000-12-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE PREPMATE ACCESSORY (PREPMATE METHOD), WHICH AUTOMATES THE INITIAL MANUAL STEPS OF THE AUTOCYTE PREP LABORATORY PROCESS. THE PREPMATE AUTOMATICALLY MIXES AND REMOVES THE SPECIMEN FROM THE GYN PRESERVATIVE VIALS, AND LAYERS THE SPECIMEN ONTO CYTORICH DENSITY REAGENT IN A TEST TUBE, AND FOR THE ADDITION OF THE MANUAL METHOD, IN WHICH, RATHER THAN USING THE AUTOCYTE PREP SYSTEM FOR CELL SUSPENSION AND SLIDE STAINING, THE CELL SUSPENSION IS MANUALLY LAYERED ONTO THE SLIDE AND STAINED BY A LABORATORY TECHNICIAN.