PROGENSA PCA3 ASSAY
FDA premarket approval P100033/S005 · decided 2015-07-09
Approval details
- PMA number
- P100033
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROGENSA PCA3 ASSAY
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Applicant
- Gen-Probe Incorporated
- Date received
- 2015-06-12
- Decision date
- 2015-07-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OYM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- EXTENSION OF THE PRE-CLEANING AND POST-CLEANING HOLD TIMES FOR AUTOMATED CLEANING OF STAINLESS STEEL TANKS USED IN THE MANUFACTURE OF THE SELECTION REAGENT FOR THE PROGENSA PCA3 ASSAY. IN ADDITION, A MANUAL CLEANING PROCESS OPTION IS ADDED FOR THE STAINLESS STEEL TANKS AS A BACKUP METHOD.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |