Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Basic Information
- Device Name
- Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Trade Name
- ABBOTT AXSYM FREE PSA ASSAY
- PMA Number
- P980007
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- MTG
- Generic Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 10, 2004
- Date Received
- August 5, 2004
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF FLOMAX TO THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT AND MINOR LABELING CHANGES TO THE ABBOTT AXSYM FREE PSA ASSAY FOR THE PURPOSE OF CLARIFICATION, UPDATES AND CONFORMATION TO REQUIREMENTS OF THE EUROPEAN COMMUNITY DIRECTIVES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AXSYM FREE PSA ASSAY AND IS INDICATED AS FOLLOWS: THE AXSYM FREE PSA ASSAY 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | FDA class 3 | Unknown |