Cytomegalovirus (Cmv) Dna Quantitative Assay
Basic Information
- Device Name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Trade Name
- COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
- PMA Number
- P110037
- Device Class
- FDA Class 2
- Product Code
- PAB
- Generic Name
- Cytomegalovirus (cmv) dna quantitative assay
- Regulation Number
- 866.3180
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- July 5, 2012
- Date Received
- October 24, 2011
- Expedited Review
- N
- Docket Number
- 12M-0713
Advisory Committee Statement
APPROVAL FOR THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST. THIS DEVICE IS INDICATED FOR: THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMENPROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID-ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. IN THIS POPULATION SERIAL DNA MEASUREMENTS CAN BE USED TO ASSESS VIROLOGICAL RESPONSE TO ANTIVIRAL TREATMENT. THE RESULTS FROM THE COBAS AMPLIPREP/COBAS TAQMAN CMVTEST MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF CMV DNA IN BLOOD OR BLOOD PRODUCTS.
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 |
|---|---|---|---|
| PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | FDA class 2 | Microbiology |