Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Basic Information
- Device Name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Trade Name
- HOME ACCESS HEPATITIS C CHECK
- PMA Number
- P980046
- Supplement Number
- S009
- 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
- December 9, 2015
- Date Received
- September 22, 2015
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for: 1. Removal of testing with the CHIRON® RIBA® HCV 3.0 SIA (RIBA) from the laboratory protocol; 2. Reporting of repeatedly reactive specimens as Presumptive HCV Infection; 3. Reporting of specimens for which antibodies to the hepatitis C virus were not found as Negative; 4. Home Access Hepatitis C Check had previously identified either Indeterminate or Positive as the reportable result, the communication will now be the same for both types of results: consider yourself infected with the hepatitis C virus until further testing, consult a physician of your choice and seek NAT for HCV RNA: Presumptive HCV Infection; and5. Revision of the informational brochure Answers to Frequently Asked Questions about Hepatitis C to exclude reference to RIBA® as part of the laboratory protocol and to modify the definition of results to reflect Presumptive HCV Infection.
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 |