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PMA P970018S017

Device
BD PREPSTAIN SYSTEM
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S017
Product code
MKQ
Decision date
2009-11-16
Generic name
Processor, cervical cytology slide, automated
Approval order statement
APPROVAL FOR A MODIFICATION TO THE INTENDED USE OF THE PREPSTAIN SYSTEM TO ALLOW FOR THE REMOVAL OF A 0.5 ML ALIQUOT OF THE PATIENT SPECIMEN COLLECTED IN THE SUREPATHPRESERVATIVE FLUID COLLECTION VIAL, PRIOR TO PROCESSING WITH THE PREPSTAIN SYSTEM, FOR TESTINGWITH THE BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE(GC) QX (GCQ) AMPLIFIED DNA ASSAYS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME PREPSTAIN SYSTEM (FORMERLY THE AUTOCYTE PREP SYSTEM) AND IS INDICATED FOR ALIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDESTHAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGICAL PAP SMEARS. SUREPALH SLIDES (FORMERLY THE AUTOCYTE PREP SLIDES) ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OFCERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATHPRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGICSPECIMENS TESTED WITH BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIAGONORRHOEAE (GC) QX (GCQ) AMPLIFIED DNA ASSAYS.

Current openFDA PMA Record#

Device
BD PREPSTAIN SYSTEM
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S017
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2009-11-16
Decision code
APPR
Date received
2009-06-11
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MODIFICATION TO THE INTENDED USE OF THE PREPSTAIN SYSTEM TO ALLOW FOR THE REMOVAL OF A 0.5 ML ALIQUOT OF THE PATIENT SPECIMEN COLLECTED IN THE SUREPATHPRESERVATIVE FLUID COLLECTION VIAL, PRIOR TO PROCESSING WITH THE PREPSTAIN SYSTEM, FOR TESTINGWITH THE BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE(GC) QX (GCQ) AMPLIFIED DNA ASSAYS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME PREPSTAIN SYSTEM (FORMERLY THE AUTOCYTE PREP SYSTEM) AND IS INDICATED FOR ALIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDESTHAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGICAL PAP SMEARS. SUREPALH SLIDES (FORMERLY THE AUTOCYTE PREP SLIDES) ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OFCERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATHPRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGICSPECIMENS TESTED WITH BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIAGONORRHOEAE (GC) QX (GCQ) AMPLIFIED DNA ASSAYS.