Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSet
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151786 FDA 510(k)
- FDA Product Code
- CDD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1810 FDA 510(k)
- Regulation Number
- 862.1810 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys Vitamin B12 II Assay is an electrochemiluminescence immunoassay (ECLIA) designed for the in vitro quantitative determination of vitamin B12 in human serum and plasma. This device falls under the category of radioassay systems and is intended for use on Roche Elecsys and cobas e immunoassay analyzers to support diagnostic and treatment monitoring for conditions related to vitamin B12 deficiency.
The Elecsys Vitamin B12 II Assay is supplied as a single-use reagent system for in vitro diagnostic use, requiring calibration with the Elecsys Vitamin B12 II CalSet. It is regulated under FDA 510(k) clearance (K151786) as a Class II device, adhering to regulatory standards for clinical chemistry applications. The assay is not MRI-compatible and must be stored and handled according to manufacturer guidelines to maintain performance integrity.
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: Elecsys Vitamin B12 II - Roche, Vitamin B12 II CalSet - Roche, Elecsys® Vitamin B12 II - Roche Diagnostics USA, Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786 ..., Elecsys Vitamin B12 II Assay Overview - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151786 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K151786 24 fields · synced Oct 6, 2026