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 TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET
- PMA Number
- P990056
- Supplement Number
- S001
- 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
- February 8, 2002
- Date Received
- October 9, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF THE ASSAY TO THE MODULAR ANALYTICS E170 (ELECSYS MODULE) IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS TOTAL PSA IMMUNOASSAY AND ELECSYS TOTAL PSA CALSET AND ARE INDICATED AS FOLLOWS: THE ELECSYS TOTAL PSA IMMUNOASSAY, A QUANTITATIVE IN VITRO DIAGNOSTIC TEST FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) IN HUMAN SERUM AND PLASMA, IS INDICATED FOR THE MEASUREMENT OF TOTAL PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS OR OLDER. PROSTATE BIOPSY IS REQUIRED FOR DIAGNOSIS OF PROSTATE CANCER. THE TEST IS FURTHER INDICATED FOR SERIAL MEASUREMENT OF TPSA TO AID IN THE MANAGEMENT OF CANCER PATIENTS. THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 1010/2010 AND MODULAR ANALYTICS E170 (ELECSYS MODULE) 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 |