ABBOTT IMX TOTAL PSA
FDA premarket approval P910007/S013 · decided 2005-06-13
Approval details
- PMA number
- P910007
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT IMX TOTAL PSA
- Generic name
- Analyzer, chemistry (photometric, discrete), for clinical use
- Applicant
- Abbott Laboratories
- Date received
- 2005-05-05
- Decision date
- 2005-06-13
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- JJE
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL OF THE NEW METHOD COMPARISONS BETWEEN THE IMX TOTAL PSA ASSAY AND THE IMX PSA ASSAY. THE COMPARISONS INCLUDE REGRESSION ANALYSES (PASSING-BABLOK AND LEAST SQUARES LINEAR REGRESSION) AND BIAS ANALYSIS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IMX TOTAL PSA ASSAY AND IS INDICATED AS FOLLOWS: THE IMX TOTAL PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF TOTAL PSA (BOTH FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPS
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