Hepatitis Viral B Dna Detection
Basic Information
- Device Name
- Hepatitis Viral B Dna Detection
- Trade Name
- COBAS TAQMAN HBV TEST
- PMA Number
- P050028
- Device Class
- FDA Class 3
- Product Code
- MKT
- Generic Name
- Hepatitis Viral B DNA Detection
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 4, 2008
- Date Received
- August 2, 2005
- Expedited Review
- N
- Docket Number
- 08M-0501
Advisory Committee Statement
APPROVAL FOR COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THIS DEVICE IS INDICATED FOR: THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA), USING THE HIGH PURE VIRAL NUCLEIC ACID KIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE COBAS TAQMAN HBV TEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIR DIPIVOXIL. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HBV INFECTION HAS NOT BEEN ESTABLISHED. THE COBAS TAQMAN HBV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR BLOOD OR BLOOD PRODUCTS FOR THE PRESENCE OF HBV OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV 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 |
|---|---|---|---|
| MKT | Hepatitis Viral B Dna Detection | FDA class 3 | Unknown |