BD PREPSTAIN SYSTEM
FDA premarket approval P970018/S017 · decided 2009-11-16
Approval details
- PMA number
- P970018
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD PREPSTAIN SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Bd Diagnostic Systems
- Date received
- 2009-06-11
- Decision date
- 2009-11-16
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BD BACTEC FXI Culture System (K260213) | BD Diagnostic Systems | 2026-05-28 |
| PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) (K032518) | Bd Diagnostic Systems | 2003-09-15 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (K032153) | Bd Diagnostic Systems | 2003-09-11 |
| PASCO MIC AND MIC/ID PANELS (K032259) | Bd Diagnostic Systems | 2003-08-19 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (K031429) | Bd Diagnostic Systems | 2003-06-06 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (K030091) | Bd Diagnostic Systems | 2003-02-28 |