Cytomegalovirus (Cmv) Dna Quantitative Assay
Basic Information
- Device Name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Trade Name
- ARTUS CMV RGQ MDX KIT
- PMA Number
- P130027
- 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
- June 2, 2014
- Date Received
- December 5, 2013
- Expedited Review
- N
- Docket Number
- 14M-0866
Advisory Committee Statement
APPROVAL FOR THE ARTUS CMV RGQ MDX KIT. THIS DEVICE IS INDICATED FOR: THE ARTUS CMV RGQ MDX KIT IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HUMAN CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA. THE ARTUS CMV RGQ MDX KIT IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF SOLID ORGAN TRANSPLANT PATIENTS WHO ARE UNDERGOING ANTI-CMV THERAPY. THE TEST MEASURES CMV DNA LEVELS IN EDTA PLASMA AND CAN BE USED TO ASSESS CMV VIRAL LOAD RESPONSE TO ANTIVIRAL DRUG THERAPY. THE RESULTS FROM THE ARTUS CMV RGQ MDX KIT MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THE ARTUS CMV RGQ MDX KIT IS CONFIGURED FOR USE WITH THE EZ1 DSP VIRUS SYSTEM (EZ1 DSP VIRUS KIT AND EZ1 ADVANCED INSTRUMENTS) FOR DNA EXTRACTION AND THE ROTOR-GENE Q MDX INSTRUMENT FOR CMV DNA AMPLIFICATION AND QUANTITATION. THE ARTUS CMV RGQ MDX KIT IS NOT INTENDED FOR USE AS A SCREENING TEST FOR 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 |