Elecsys Folate II Immunoassay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043318 FDA 510(k)
- FDA Product Code
- CGN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1295 FDA 510(k)
- Regulation Number
- 862.1295 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys Folate II Immunoassay is a binding assay designed for the in vitro quantitative determination of folate concentrations in human serum. Classified as an acid folic radioimmunoassay, this device leverages immunoassay technology to provide precise measurements of folate levels, supporting clinical chemistry applications.
This modification is intended for use exclusively on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. Supplied as a reagent system, the device is intended for single-use in clinical laboratory settings. The modification received FDA 510(k) clearance under Special Controls (product code CGN) and is regulated under 21 CFR 862.1295. No additional sterility or MRI safety considerations are specified.
Frequently asked questions
What is the Roche Elecsys Folate II Immunoassay Modification used for?
This modification is designed for the in vitro quantitative determination of folate concentrations in human serum. It leverages immunoassay technology to provide accurate measurements, supporting clinical chemistry applications such as assessing vitamin B9 levels for patient diagnostics.
On which analyzers can this modification be used?
The modification is exclusively intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. It is not compatible with other systems or platforms.
How is the Roche Elecsys Folate II Immunoassay Modification supplied?
The device is supplied as a reagent system, specifically formulated for single-use in clinical laboratory settings. Each reagent system is intended for one-time use only, ensuring precision and consistency in folate measurements.
Is sterility or MRI safety a consideration for this modification?
No additional sterility or MRI safety considerations are specified for this modification. It is designed for use in clinical laboratory environments where standard safety protocols apply.
What regulatory pathway does this modification follow?
The modification received FDA 510(k) clearance under Special Controls (product code CGN) and is regulated under 21 CFR 862.1295. It was determined to be substantially equivalent to a predicate device, ensuring compliance with regulatory standards for clinical chemistry assays.
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: Modification to Roche Elecsys Folate Ii Immunoassay, K043318 FDA 510(k) - MODIFICATION TO ROCHE ELECSYS FOLATE II..., PDF K043318 - Modification to Roche Elecsys Folate Ii Immunoassay, Modification to Roche Elecsys Folate Ii Calcheck Ii
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043318 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K043318 24 fields · synced Oct 1, 2026