Identity
- Trade Name
- ARTUS CMV RGQ MDX KIT FDA PMA
- Generic Name
- Cytomegalovirus (cmv) dna quantitative assay FDA PMA
Identifiers
- PMA Number
- P130027 FDA PMA
- FDA Product Code
- PAB FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3180 FDA PMA
- Regulation Number
- 866.3180 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Artus CMV RGQ MDX Kit is an in vitro nucleic acid amplification test designed for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma. Classified under microbiology, this device enables precise measurement of viral load to aid in the management of CMV infection, particularly in solid organ transplant patients undergoing antiviral therapy.
The kit is configured for use with the EZ1 DSP Virus System (including the EZ1 DSP Virus Kit and EZ1 Advanced Instruments) for DNA extraction and the Rotor-Gene Q MDX instrument for amplification and quantitation. Supplied as a single-use diagnostic reagent, it requires laboratory processing and is intended for use in clinical microbiology settings. Approved under PMA number P130027, it adheres to regulatory standards for in vitro diagnostic devices.
Frequently asked questions
What specific patient population is the ARTUS CMV RGQ MDX Kit designed to support in clinical decision-making?
The ARTUS CMV RGQ MDX Kit is specifically designed to aid in the management of solid organ transplant patients undergoing antiviral therapy for cytomegalovirus (CMV) infection. It quantifies CMV DNA levels in EDTA plasma to help assess viral load and monitor response to treatment, ensuring tailored clinical intervention.
How is the ARTUS CMV RGQ MDX Kit intended to be used in a clinical laboratory setting?
The kit requires laboratory processing and is configured for use with the EZ1 DSP Virus System (including the EZ1 DSP Virus Kit and EZ1 Advanced Instruments) for DNA extraction, followed by amplification and quantitation on the Rotor-Gene Q MDX instrument. It is a single-use diagnostic reagent and must be integrated into existing workflows for nucleic acid testing.
What sample type and preparation is required for testing with the ARTUS CMV RGQ MDX Kit?
The kit is designed for use with human EDTA plasma samples only. No additional preparation beyond standard plasma collection is specified, but results must be interpreted alongside all relevant clinical and laboratory findings to ensure accurate patient management.
Is the ARTUS CMV RGQ MDX Kit approved for screening blood or blood products?
No, the kit is not intended for use as a screening test for blood or blood products. Its sole indication is quantifying CMV DNA in EDTA plasma to support antiviral therapy monitoring in solid organ transplant patients.
What regulatory pathway was followed for the approval of the ARTUS CMV RGQ MDX Kit?
The kit was approved under the Premarket Approval (PMA) pathway (PMA number P130027) by the FDA, adhering to regulatory standards for in vitro diagnostic devices. This pathway is typically used for higher-risk medical devices requiring substantial evidence of safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130027 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA PMA P130027 24 fields · synced Sep 18, 2026