PMA P910007S013

Device: ABBOTT IMX TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S013
Product code: JJE
Decision date: 2005-06-13
Generic name: Analyzer, chemistry (photometric, discrete), for clinical use
Approval order 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-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 IMX TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S013
Product code: JJE
Generic name: Analyzer, chemistry (photometric, discrete), for clinical use
Decision date: 2005-06-13
Decision code: APPR
Date received: 2005-05-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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-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.