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Ceruloplasmin (K161508)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161508

by Beckman Coulter Ireland Inc.

Identifiers

510(k) Number
K161508 FDA 510(k)
FDA Product Code
DDB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5210 FDA 510(k)
Regulation Number
866.5210 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ceruloplasmin (K161508) is an antigen, antiserum, and control reagent classified under the nomenclature for immunology diagnostics. It serves as a reference standard for the quantitative measurement of ceruloplasmin in human serum and plasma, aiding in the assessment of copper metabolism disorders and Wilson’s disease diagnostics. The product is designed to ensure accuracy and consistency in laboratory testing on Beckman Coulter AU analyzers. Its role is critical in validating assay performance and confirming analytical precision.

This reagent is supplied as a single-use diagnostic control for in vitro use in clinical laboratories. It is intended for use with Beckman Coulter AU series analyzers and requires storage under refrigerated conditions (2–8°C) to maintain stability. The device holds FDA 510(k) clearance (K161508) and complies with In Vitro Diagnostic Regulation (IVDR) standards. No sterilization or reprocessing is required, as it is intended for one-time use per assay. Regulatory filings classify it under Device Class II (DDB) for immunology applications.

Frequently asked questions

What clinical conditions is this ceruloplasmin reagent primarily used to diagnose or monitor?

This ceruloplasmin reagent is specifically designed to aid in the assessment of copper metabolism disorders and the diagnosis of Wilson’s disease. It serves as a reference standard for quantitative measurement in human serum and plasma, helping laboratories validate assay accuracy and precision for these conditions.

How should this product be stored to ensure it remains stable and effective?

The ceruloplasmin reagent must be stored under refrigerated conditions between 2–8°C to maintain its stability. This temperature range is critical for preserving its integrity before use in clinical assays.

Is this reagent reusable, or is it intended for single-use per assay?

This ceruloplasmin reagent is explicitly intended for single-use per assay. It is not sterilized for reuse or reprocessing, so each vial should be used once and then discarded to ensure accurate and reliable diagnostic results.

Which Beckman Coulter analyzers is this reagent compatible with?

The ceruloplasmin reagent is designed for use exclusively with Beckman Coulter AU series analyzers. Compatibility is limited to these platforms to ensure accurate and consistent assay performance.

What regulatory standards does this product comply with, and how does it classify under FDA and IVDR?

This reagent holds FDA 510(k) clearance under the classification K161508 and is also compliant with the In Vitro Diagnostic Regulation (IVDR). It is categorized as a Device Class II (DDB) for immunology applications, reflecting its role as a diagnostic control reagent.

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: Part | Beckman Coulter, Beckman Coulter Ireland, Ceruloplasmin (K161508) — FDA 510 (k) | Innolitics, K161508 - Ceruloplasmin, Antigen, Antiserum, Control FDA 510 (k ..., Ceruloplasmin 510 (k) FDA Premarket Notification K161508 BECKMAN ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beckman Coulter Ireland Inc.
FDA Applicant
Beckman Coulter Ireland, Inc.

Sources (2)

  • FDA 510(k) K161508 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026