PMA P910007S011

Device: ABBOTT AXSYM TOTAL PSA ASSAY
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S011
Product code: JJE
Decision date: 2004-09-27
Generic name: Analyzer, chemistry (photometric, discrete), for clinical use
Approval order 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 FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.

Current openFDA PMA Record#

Device: ABBOTT AXSYM TOTAL PSA ASSAY
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S011
Product code: JJE
Generic name: Analyzer, chemistry (photometric, discrete), for clinical use
Decision date: 2004-09-27
Decision code: APPR
Date received: 2004-07-29
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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 FREE PSA AND PSA COMPLEXED TO ALPHA-1-ANTICHYMOTRYPSIN) IN HUMAN SERUM: 1) AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) IN MEN 50 YEARS OR OLDER. PROSTATIC BIOPSY IS REQUIRED FOR DIAGNOSIS OF CANCER. 2) AS AN ADJUNCTIVE TEST TO AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS.