Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Basic Information
- Device Name
- Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Trade Name
- ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
- PMA Number
- P000027
- Device Class
- FDA Class 2
- Product Code
- LTJ
- Generic Name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 12, 2000
- Date Received
- July 7, 2000
- Expedited Review
- N
- Docket Number
- 00M-1683
Advisory Committee Statement
APPROVAL FOR THE ELECSYS(R) FREE PSA IMMUNOASSAY FOR ELECSYS 1010 AND 2010 IMMUNOASSAY ANALYZERS. THE DEVICE IS INDICATED FOR: THE IN VITRO QUANTITATIVE DETERMINATION OF FREE PROSTATE-SPECIFIC ANTIGEN IN HUMAN SERUM AND PLASMA. THE ELECSYS FREE PSA IMMUNOASSAY IS INDICATED FOR MEASUREMENT OF FPSA IN CONJUNCTION WITH THE ELECSYS TOTAL PSA ASSAY TO DEVELOP A RATIO (% FPSA) OF FPSA TO TPSA. THIS RATIO IS USEFUL WHEN USED IN CONJUNCTION WITH THE ELECSYS TOTAL PSA TEST AS AN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIOND IN MEN AGE 50 YEARS OR OLDER WHO HAVE A DIGITAL RECTOAL EXAMINATION (DRE) THAT IS NOT SUSPICIOUS FOR PROSTATE CANCER AND AN ELECSYS TOTAL PSA VALUE IN THE RANGE 4 NG/ML TO 10 NG/ML. PROSTATE BIOPSY IS REQUIRED FOR THE DIAGNOSIS OF PROSTATE CANCER. THE ELECTROCHEMILUMINESCENE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010 AND 2010 IMMUNOASSAY ANALYZERS.
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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |