Identifiers
- 510(k) Number
- K171605 FDA 510(k)
- FDA Product Code
- MOI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6010 FDA 510(k)
- Regulation Number
- 866.6010 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys CA 15-3 II is an immunological test system used for the quantitative determination of the tumor marker CA 15-3 in human serum and plasma. This test is designed to assist in the monitoring of patients with metastatic breast cancer.
The device is supplied as a component of the Elecsys system and is intended for in vitro diagnostic use. It is a Class II device cleared by the FDA under 510(k) K171605, with the product code MOI. The device is not specified as single-use or reusable, and no MRI safety information is provided in the data.
Frequently asked questions
What is the Elecsys CA 15-3 II test used for?
The Elecsys CA 15-3 II is an immunological test system used for the quantitative determination of the tumor marker CA 15-3 in human serum and plasma. It is designed to assist in monitoring patients with metastatic breast cancer.
How is the Elecsys CA 15-3 II supplied?
The device is supplied as a component of the Elecsys system and is intended for in vitro diagnostic use. It is a Class II device cleared by the FDA under 510(k) K171605, with the product code MOI.
Is the Elecsys CA 15-3 II single-use or reusable?
The device is not specified as single-use or reusable in the provided data. Users should refer to the manufacturer's instructions for specific guidance on usage and disposal.
What regulatory approvals does the Elecsys CA 15-3 II have?
The Elecsys CA 15-3 II is a Class II device cleared by the FDA under 510(k) K171605 with the product code MOI. It received FDA clearance on February 20, 2018, after being reviewed by the Immunology advisory committee.
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171605 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K171605 24 fields · synced Sep 23, 2026