Identity
- Trade Name
- Alinity m CMV FDA PMA
- Generic Name
- Cytomegalovirus (cmv) dna quantitative assay 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
- SESE Substantially Equivalent FDA PMA
The Alinity m CMV AMP Kit is an in vitro polymerase chain reaction (PCR) assay designed for quantitative detection of cytomegalovirus (CMV) DNA in human EDTA plasma. Classified as a microbiology device under FDA nomenclature, it is intended for use on the automated Alinity m System to aid in managing transplant patients undergoing anti-CMV therapy, including hematopoietic and solid organ transplant recipients.
The assay is supplied as a kit for use with the Alinity m System, including controls (Alinity m CTRL Kit) and calibrators (Alinity m CAL Kit) for validation and quantitative calibration. It is intended for single-use in clinical laboratory settings and has received FDA 510(k) and PMA authorizations. No MRI safety or sterility specifications are noted in the provided data.
Frequently asked questions
What clinical scenarios is the Alinity m CMV assay primarily designed to support in transplant patients?
The Alinity m CMV assay is designed to aid in managing **hematopoietic stem cell transplant (HSCT) and solid organ transplant recipients** undergoing anti-CMV therapy. It quantifies CMV DNA in EDTA plasma to help assess virological response to treatment, ensuring better monitoring of viral load during therapy. However, it is **not intended as a screening test** for CMV in blood or blood products.
How is the Alinity m CMV assay supplied, and what additional components are required for use?
The assay is supplied as a **single-use kit** for the automated Alinity m System. To perform quantitative testing, you’ll also need the **Alinity m CTRL Kit** (for validity checks) and the **Alinity m CAL Kit** (for calibration). These components are essential for accurate results and must be used in conjunction with the assay as specified in the package insert.
Is the Alinity m CMV assay reusable, or is it intended for one-time clinical use?
The Alinity m CMV assay is **intended for single-use only** in clinical laboratory settings. This design ensures consistency and reduces the risk of cross-contamination, which is critical for accurate CMV DNA quantification in patient samples.
What type of sample does the Alinity m CMV assay require, and are there specific handling instructions?
The assay requires **human EDTA plasma** as the sample type. EDTA plasma must be properly collected and handled per standard laboratory protocols to ensure compatibility with the PCR-based assay. The assay is designed exclusively for use on the **Alinity m System**, so sample preparation must align with the system’s requirements.
How does the Alinity m CMV assay differ from other CMV tests in terms of its intended use?
Unlike screening tests for CMV in blood or blood products, the Alinity m CMV assay is **specifically intended for quantitative detection of CMV DNA in EDTA plasma** to monitor transplant patients on anti-CMV therapy. It provides virological response data to support clinical decisions in **HSCT and solid organ transplant** settings, helping tailor treatment based on viral load trends rather than qualitative presence.
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. Sources consulted: Alinity | Core Laboratory bei Abbott, Alinity | Core Laboratory at Abbott, Alinity n - transfusion.abbott
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243485 | Class II | Active |
| FDA PMA | United States | FDA_PMA | P210022 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (2)
- FDA PMA P210022 37 fields · synced Sep 18, 2026
- FDA 510(k) K243485 1 fields · synced May 18, 2026