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K-Assay Hs-Crp Controls

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022486

by Kamiya Biomedical Co.

Identifiers

510(k) Number
K022486 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 HS-CRP CONTROLS are quality control materials designed for monitoring the performance of C-Reactive Protein (CRP) immunoturbidimetric assays. These controls are intended for use in clinical diagnostic laboratories to ensure the accuracy and precision of CRP testing.

The device is supplied as assayed quality control material and is intended for single-use in laboratory settings. It is regulated under FDA 510(k) clearance with product code DCK and is classified as a Class II device for immunology testing. The controls are designed for use with automated chemistry analyzers and should be stored according to the manufacturer's instructions.

Frequently asked questions

What are K-ASSAY HS-CRP Controls used for?

These controls are quality control materials designed for monitoring the performance of C-Reactive Protein (CRP) immunoturbidimetric assays in clinical diagnostic laboratories to ensure testing accuracy and precision.

How are K-ASSAY HS-CRP Controls supplied and what is their intended use?

The controls are supplied as assayed quality control material and are intended for single-use in laboratory settings. They are designed specifically for use with automated chemistry analyzers to monitor CRP testing performance.

What is the regulatory classification of K-ASSAY HS-CRP Controls?

The device is regulated under FDA 510(k) clearance with product code DCK and is classified as a Class II device for immunology testing. It received FDA clearance on August 14, 2002, with K number K022486.

How should K-ASSAY HS-CRP Controls be stored?

The controls should be stored according to the manufacturer's instructions to maintain their integrity and ensure proper performance in laboratory settings.

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: Kamiya Biomedical Company - Clinical Diagnostics - hsCRP / High ..., Kamiya Biomedical Company - Clinical Diagnostics - High-Sensitive CRP ..., Kamiya Biomedical Company - Clinical Diagnostics - hsCRP / High ..., K-ASSAY HS-CRP CONTROLS by KAMIYA BIOMEDICAL CO. | FDA 510 (k) Summary, Kamiya Biomedical Company - Clinical Diagnostics - hsCRP / High ...

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) K022486 24 fields · synced Oct 6, 2026