cobas CMV Test
FDA PMAFDA 510(k)Class II (US FDA PMA)
Identity
- Trade Name
- COBAS 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 cobas CMV Test is an in vitro nucleic acid amplification assay for the quantitative detection of cytomegalovirus (CMV) DNA in human EDTA plasma. Classified as a microbiology device under the FDA’s nomenclature, it provides measurable viral load results to aid in clinical decision-making for CMV management.
This test is intended for use in solid organ and hematopoietic stem cell transplant patients to monitor CMV infection and assess response to anti-CMV therapy. Supplied as a single-use reagent kit, it requires laboratory processing and is not approved for blood screening. Authorized under FDA 510(k) clearance (K252481) and PMA (P160041), compliance with regulatory standards ensures accurate quantitation of CMV DNA for clinical management.
Frequently asked questions
What specific patient populations is the cobas CMV Test designed to monitor for cytomegalovirus (CMV) management?
The cobas CMV Test is specifically intended for use in solid organ transplant patients and hematopoietic stem cell transplant patients to monitor CMV infection and evaluate their response to anti-CMV therapy. It is not approved for general blood screening or use in non-transplant populations.
How is the cobas CMV Test supplied, and is it reusable?
The cobas CMV Test is supplied as a single-use reagent kit, meaning each kit is designed for one-time use in a laboratory setting. This ensures consistency and reduces the risk of cross-contamination, as reuse is not supported or intended.
What type of sample does the cobas CMV Test require, and how should it be collected?
The cobas CMV Test requires human EDTA plasma as the sample type. EDTA plasma must be collected using tubes containing EDTA anticoagulant, as this is the specified matrix for accurate CMV DNA detection and quantitation.
Can the cobas CMV Test be used to screen blood or blood products for CMV?
No, the cobas CMV Test is explicitly **not intended** for use as a screening test for blood or blood products. Its purpose is limited to monitoring CMV viral load in solid organ and hematopoietic stem cell transplant patients to aid in clinical decision-making.
What regulatory pathways does the cobas CMV Test follow, and how does this affect its use?
The cobas CMV Test is authorized under both FDA 510(k) clearance (K252481) and PMA (P160041), confirming compliance with U.S. regulatory standards for microbiology devices. This ensures its performance meets established benchmarks for quantifying CMV DNA in EDTA plasma, supporting reliable clinical management in transplant patients.
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_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252481 | Class II | Active |
| FDA PMA | United States | FDA_PMA | P160041 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (2)
- FDA PMA P160041 37 fields · synced Sep 18, 2026
- FDA 510(k) K252481 1 fields · synced May 18, 2026