IMMULITE FPSA ASSAY
FDA premarket approval P060005/S008 · decided 2012-11-08
Approval details
- PMA number
- P060005
- Supplement
- S008
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE FPSA ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- Date received
- 2012-05-30
- Decision date
- 2012-11-08
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55
- Statement
- APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.