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Randox Complement C4

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000468

by Randox Laboratories, Ltd.

Identifiers

510(k) Number
K000468 FDA 510(k)
FDA Product Code
DBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5240 FDA 510(k)
Regulation Number
866.5240 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Randox Complement C4 is an Antigen, Antiserum, and Control reagent designed for the quantitative in vitro measurement of complement C4 concentration in serum. It falls under the category of immunology diagnostics, specifically for assessing complement system proteins. This assay supports diagnostic evaluation of autoimmune conditions linked to altered complement C4 levels, such as systemic lupus erythematosus and rheumatoid arthritis.

This reagent is supplied as part of a traditionally cleared (FDA 510(k)) diagnostic kit, intended for use in clinical laboratories. It is intended for single-use applications and requires no special handling beyond standard reagent storage conditions. The device is classified under FDA regulation 866.5240 and is distributed by Randox Laboratories, Ltd., based in Antrim, Northern Ireland. No additional sterility or MRI safety considerations are specified.

Frequently asked questions

What is the Randox Complement C4 assay kit used for?

The Randox Complement C4 assay kit is designed for the quantitative in vitro measurement of complement C4 concentration in serum. It aids in the diagnostic evaluation of autoimmune conditions where complement C4 levels may be altered, such as systemic lupus erythematosus and rheumatoid arthritis. By providing precise C4 measurements, clinicians can better assess immune system activity and guide patient management.

How is the Randox Complement C4 kit supplied, and is it single-use?

The Randox Complement C4 kit is supplied as part of a diagnostic reagent kit, containing antigen, antiserum, and control reagents. It is intended for single-use applications only, meaning each kit is designed for one testing procedure. This ensures accuracy and prevents cross-contamination between samples, adhering to standard clinical laboratory practices.

Does the Randox Complement C4 kit require special handling or storage?

No special handling is required beyond standard reagent storage conditions for the Randox Complement C4 kit. It should be stored according to the manufacturer’s guidelines, typically at room temperature or refrigerated, depending on the specific components. Proper storage ensures the reagents remain stable and effective for their intended use in measuring complement C4 levels.

What regulatory pathway does the Randox Complement C4 kit follow?

The Randox Complement C4 kit follows the traditional (FDA 510(k)) regulatory pathway, as indicated by its clearance status. This means it was reviewed by the FDA’s Immunology (IM) advisory committee and determined to be substantially equivalent to a predicate device. The kit is classified under FDA regulation 866.5240 and is distributed by Randox Laboratories, Ltd., based in Northern Ireland.

Are there any sterility or MRI safety considerations for this device?

The Randox Complement C4 kit does not specify any additional sterility requirements beyond standard reagent handling practices. There are also no MRI safety considerations mentioned for this device, as it is intended for in vitro diagnostic use in clinical laboratories and not for use in MRI environments. Always follow local laboratory protocols for reagent handling.

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: Complement C4 | Biochemistry | Reagent | Randox Laboratories, Randox Featured Reagent Complement C4 - Randox Laboratories, RANDOX COMPLEMENT C4 (K000468) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA 510(k) K000468 24 fields · synced Oct 1, 2026