Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Basic Information
- Device Name
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Trade Name
- ABBOTT IMX TOTAL PSA
- PMA Number
- P910007
- Supplement Number
- S013
- Device Class
- FDA Class 1
- Product Code
- JJE
- Generic Name
- Analyzer, chemistry (photometric, discrete), for clinical use
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 13, 2005
- Date Received
- May 5, 2005
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |