Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Basic Information
- Device Name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Trade Name
- ELECSYS ANTI-HCV IMMUNOASSAY
- PMA Number
- P090008
- Supplement Number
- S006
- 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
- April 25, 2012
- Date Received
- November 1, 2011
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE EXTENSION OF THE ELECSYS ANTI-HCV IMMUNOASSAY ANDPRECICONTROL ANTI-HCV IMMUNOASSAY ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HCV IMMUNOASSAY AND IS INDICATED FOR: ELECSYS ANTI-HCV IMMUNOASSAY - THE ELECSYS ANTI-HCV IMMUNOASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THIS TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE. THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON COBAS E 601 AND COBAS E 602 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 |
|---|---|---|---|
| MZO | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus | FDA class 2 | Unknown |