Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Basic Information
- Device Name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Trade Name
- ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER
- PMA Number
- P090009
- 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 (Reclassification)
- Decision Code
- APRL
- Decision Date
- April 29, 2010
- Date Received
- May 15, 2009
- Expedited Review
- N
- Docket Number
- 10M-0264
Advisory Committee Statement
APPROVAL FOR THE ELECSYSANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV ASSAY FOR USE ON MODULAR ANALYTICS E170 ANALYZER. THIS DEVICE IS INDICATED FOR:ELECSYS ANTI-HCV IMMUNOASSAYTHE ROCHE ELECSYS ANTI-HCV ASSAY 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 WITHOTHER 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. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE. THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER.
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 |