PMA P970018S019

Device: PREPSTAIN INSTRUMENT
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S019
Product code: MKQ
Decision date: 2010-03-11
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL TO CHANGE THE DESIGN OF THE DITI (DISPOSABLE TIP) CONE OF THE PREPSTAIN INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BD PREPSTAIN¿ SYSTEM (FORMERLY AUTOCYTE®PREP SYSTEM) AND IS INDICATED FOR LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDES (FORMERLYAUTOCYTE®PREP SLIDES) THAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGIC PAPSMEARS. SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER,PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATH PRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGIC SPECIMENS TESTED WITH BDPROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE (GC) QX (GCQ)AMPLIFIED DNA ASSAYS.

Current openFDA PMA Record#

Device: PREPSTAIN INSTRUMENT
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S019
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2010-03-11
Decision code: APPR
Date received: 2009-10-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO CHANGE THE DESIGN OF THE DITI (DISPOSABLE TIP) CONE OF THE PREPSTAIN INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BD PREPSTAIN¿ SYSTEM (FORMERLY AUTOCYTE®PREP SYSTEM) AND IS INDICATED FOR LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDES (FORMERLYAUTOCYTE®PREP SLIDES) THAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGIC PAPSMEARS. SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER,PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATH PRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGIC SPECIMENS TESTED WITH BDPROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE (GC) QX (GCQ)AMPLIFIED DNA ASSAYS.