Processor, Cervical Cytology Slide, Automated
Basic Information
- Device Name
- Processor, Cervical Cytology Slide, Automated
- Trade Name
- PREPSTAIN INSTRUMENT
- PMA Number
- P970018
- Supplement Number
- S019
- Device Class
- FDA Class 3
- Product Code
- MKQ
- Generic Name
- Processor, cervical cytology slide, automated
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 11, 2010
- Date Received
- October 22, 2009
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKQ | Processor, Cervical Cytology Slide, Automated | FDA class 3 | Unknown |