Axsym Free Psa

FDA premarket approval P980007 · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

PMA numberP980007

Approval

Applicant
Abbott Laboratories
Received
March 9, 1998
Decision date
February 5, 2004 (APPR)
Supplements
55, latest February 12, 2026
Product code
MTG – Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Official FDA PMA record

Approval order statement

APPROVAL FOR THE AXSYM FREE PSA ASSAY. THE DEVICE IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) FOR THE QUANTITATIVE MEASUREMENT OF FREE PROSTATE SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM. THE AXSYM FREE PSA ASSAY IS INTENDED TO BE USED IN PSA VALUES BETWEEN 4 AND 10 NG/ML AND NON-SUSPICIOUS DRE TO DETERMINE THE % FREE PSA VALUE. THE AXSYM% FREE PSA VALUE CAN BE USED AS AN AID IN DISCRIMINATING BETWEEN PROSTATE CANCER AND BENIGN DISEASE.