UROVYSION BLADDER CANCER KIT ASSAY
FDA premarket approval P030052/S009 · decided 2012-08-10
Approval details
- PMA number
- P030052
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UROVYSION BLADDER CANCER KIT ASSAY
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Applicant
- Abbott Molecular
- Date received
- 2012-07-13
- Decision date
- 2012-08-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- ELIMINATE A SECOND CLONE IDENTITY TESTING PROCEDURE AT THE FERMENTATION STAGE FOR LSI 9P21, QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEADMIXING SYSTEM AND VALIDATION OF MIXING PROCESS IN THE MANUFACTURE OF HYBRIDIZATION BUFFER,IMPLEMENT THE OPTICAL DENSITY READING AS AN ADDITIONAL IN PROCESS QUALITY CONTROL, VALIDATE ANEXISTING MIXING PROCESS FOR THE UROVYSION BULK SOLUTION, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
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