Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Basic Information
- Device Name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Trade Name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- PMA Number
- P010021
- Supplement Number
- S007
- 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
- January 12, 2006
- Date Received
- September 16, 2005
- Supplement Type
- Normal 180 Day Track
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE REMOVAL OF THE WARNING ASSOCIATED WITH PRENATAL SCREENING AND A MODIFIED INDICATION FOR USE. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR WITH THE ADDITION OF MODEL DESIGNATIONS (ECIQ/ECI), AND IS INDICATED AS FOLLOWS:FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM. THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS, (STATE OR ASSOCIATED DISEASE NOT DETERMINED), IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS C INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HCV DURING THE PRENATAL PERIOD.
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 |