ABBOTT IMX FREE PSA

FDA premarket approval P980007/S003 · decided 2004-02-05

Approval details

PMA number: P980007
Supplement: S003
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: ABBOTT IMX FREE PSA
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Applicant: Abbott Laboratories
Date received: 2003-01-31
Decision date: 2004-02-05
Days to decision: 370 days
Decision code: APPR
Product code: MTG
Advisory committee: Immunology
Expedited review: No
Location: Abbott Park, IL
Statement: APPROVAL FOR MODIFICATION OF THE ABBOTT ARCHITECT FREE PSA REAGENTS TO BE USED WITH THE IMX FREE PSA AND IS INDICATED FOR: THE IMX FREE PSA ASSAY IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THE IMX FREE PSA ASSAY IS INTENDED TO BE USED IN CONJUNCTION WITH THE IMX TOTAL PSA ASSAY IN MEN AGED 50 YEARS OR OLDER WITH TOTAL PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALU

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