Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Basic Information
- Device Name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Trade Name
- COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0
- PMA Number
- P000012
- Device Class
- FDA Class 2
- Product Code
- MZP
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Regulation Number
- 866.3170
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- July 3, 2001
- Date Received
- February 29, 2000
- Expedited Review
- Y
- Docket Number
- 02M-0083
Advisory Committee Statement
APPROVAL FOR THE COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0. THE DEVICE IS INDICATED FOR: THE QUALITATIVE DETECTION OF HCV RNA IN HUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA). THE TEST DETECTS BY REVERSE-TRANSCRIBING TARGET HCV RNA INTO CDNA, AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY THE COBAS AMPLICOR ANALYZER. THE COBAS AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED TO BE ACTIVELY INFECTED WITH HCV. DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE 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 |
|---|---|---|---|
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | FDA class 2 | Microbiology |