Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Basic Information
- Device Name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Trade Name
- ADVIA CENTAUR HCV ON CENTAUR CP
- PMA Number
- P030056
- Supplement Number
- S002
- Device Class
- FDA Class 2
- Product Code
- MZO
- Generic Name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 13, 2009
- Date Received
- August 25, 2008
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HCV ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR HCV READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEDETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THEDIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS CINFECTION.ADVIA CENTAUR HCV QUALITY CONTROLS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV QUALITY CONTROLS ARE INTENDED FOR IN VITRO DIAGNOSTIC USE INMONITORING THE PERFORMANCE OF THE HCV ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HCV QUALITY CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HCV ASSAY.
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 |
|---|---|---|---|
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | FDA class 2 | Unknown |