Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Basic Information
- Device Name
- Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Trade Name
- IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA
- PMA Number
- P930027
- Supplement Number
- S006
- 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 31, 2003
- Date Received
- November 28, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE INTRODUCTION OF THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA TESTS FOR USE ON THE IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2500 PSA AND IMMULITE 2500 THIRD GENERATION PSA ASSAYS FOR THE FOLLOWING INDICATION: "THE IMMULITE 2500 PSA AND IMMUITE 2500 THIRD GENERATION PSA ASSAYS ARE FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2500 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER. EACH ASSAY IS FURTHER INDICATED 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 |
|---|---|---|---|
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FDA class 2 | Immunology |