Tandem-R Free Psa Immunoradiometric Assay/Tandem-Mp Free Psa Immunoenzymetric Assay

FDA premarket approval P970038 · Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

PMA numberP970038

Approval

Applicant
Beckman Coulter, Inc.
Received
August 29, 1997
Decision date
March 10, 1998 (APPR)
Supplements
42, latest May 15, 2025
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 Tandem(R)-R free PSA assay and Tandem(R)-MP free PSA assay. The Tandem(R)-R free PSA Immunoradiometric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. The Tandem(R)-MP free PSA Immunoenzymetric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. Hybritech's Tandem free PSA assays are intened to beused with Tandem (total) PSa to calculate the ration of fee PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by Hybritech's Tandem assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic condtions, when used in conjuction with Tandem (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/ml and digital rectal examination finding that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.