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K-ASSAY High Sensitive CRP(2) for the Beckman Coulter IMMAGE

FDA 510(k)

Class II (US FDA 510(k))

510(k) K002558

by Kamiya Biomedical Co.

Identifiers

510(k) Number
K002558 FDA 510(k)
FDA Product Code
DCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5270 FDA 510(k)
Regulation Number
866.5270 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The K-ASSAY High Sensitive CRP(2) is an immunological test system designed to measure C-reactive protein (CRP) in serum and other body fluids using immunochemical techniques. Classified as a C-reactive protein antigen, antiserum, and control, this device is intended for use in immunology applications to detect and quantify CRP levels, a marker often associated with inflammation and infection.

This device is supplied as a reagent kit for use exclusively with the Beckman Coulter IMMAGE immunoassay system. It is intended for in vitro diagnostic use and has received FDA 510(k) clearance under the Special classification (K002558, DCK). The kit is not described as single-use or reusable, nor is MRI safety or sterility specified in the data. Storage conditions and regulatory authorisations are limited to the stated FDA clearance and regulatory number 866.5270.

Frequently asked questions

What is the K-ASSAY High Sensitive CRP(2) designed to measure, and how does it work?

The K-ASSAY High Sensitive CRP(2) is designed to measure C-reactive protein (CRP) levels in serum and other body fluids using immunochemical techniques. CRP is a marker commonly linked to inflammation and infection, so this device quantifies its presence to aid in diagnostic evaluations within immunology applications.

Is this device compatible with any specific immunoassay system, and if so, which one?

Yes, the K-ASSAY High Sensitive CRP(2) is exclusively intended for use with the Beckman Coulter IMMAGE immunoassay system. It is supplied as a reagent kit tailored for this platform, ensuring proper functionality and compatibility.

What regulatory clearance does this device hold, and what does that mean for its use?

The K-ASSAY High Sensitive CRP(2) has received FDA 510(k) clearance under the Special classification (K002558, DCK). This means the device has been determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended immunology applications.

Is there any information provided about whether the device is single-use or reusable?

The provided data does not explicitly state whether the K-ASSAY High Sensitive CRP(2) is single-use or reusable. Since it is supplied as a reagent kit, typical usage patterns for such kits often involve single-use components, but confirmation should be verified with the manufacturer or product documentation.

What storage conditions or handling instructions are mentioned for this device?

The data does not specify storage conditions (e.g., temperature, humidity) or handling instructions for the K-ASSAY High Sensitive CRP(2). For proper use and longevity, it is recommended to refer to the manufacturer’s instructions or contact Kamiya Biomedical Co. for guidance.

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: K-ASSAY HIGH SENSITIVE CRP (2) FOR THE BECKMAN COULTER IMMAGE by KAMIYA ..., K-ASSAY HIGH SENSITIVE CRP (2) FOR THE BECKMAN COULTER IMMAGE 510 (k ..., PDF K002558 K-assay High Sensitive Crp(2) for The Beckman Coulter Immage, Beckman Coulter™ High Sensitivity C-Reactive Protein Kit

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kamiya Biomedical Co.

Sources (1)

  • FDA 510(k) K002558 24 fields · synced Oct 6, 2026