ABBOTT AXSYM TOTAL PSA ASSAY
FDA premarket approval P910007/S011 · decided 2004-09-27
Approval details
- PMA number
- P910007
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT AXSYM TOTAL PSA ASSAY
- Generic name
- Analyzer, chemistry (photometric, discrete), for clinical use
- Applicant
- Abbott Laboratories
- Date received
- 2004-07-29
- Decision date
- 2004-09-27
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- JJE
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL OF THE FOLLOWING MODIFICATIONS TO THE ABBOTT AXSYM TOTAL PSA ASSAY: 1) CHANGE THE FUNCTIONAL SENSITIVITY CLAIM TO 0.06 NG/ML 2) ADDITION OF FLOMAX TO THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT 3) MINOR LABELING CHANGES TO THE PACKAGE INSERT FOR THE PURPOSE OF CLARIFICATION, UPDATES AND CONFORMATION TO REQUIREMENTS OF THE EUROPEAN COMMUNITY DIRECTIVES. THE AXSYM TOTAL PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PSA (BOTH
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