Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Basic Information
- Device Name
- Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- Trade Name
- ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- PMA Number
- P850048
- Supplement Number
- S034
- Device Class
- FDA Class 3
- Product Code
- MTF
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 20, 2013
- Date Received
- April 12, 2013
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
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 |
|---|---|---|---|
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | FDA class 3 | Unknown |