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Radial Immuno-Test for Human C-Reactive Protein

FDA 510(k)

Class II (US FDA 510(k))

510(k) K831958

by Kent Laboratories, Inc.

Identifiers

510(k) Number
K831958 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)

This device is a C-Reactive Protein, Antigen, Antiserum, and Control as classified under FDA regulation 866.5270. It functions as an immunodiffusion assay designed to qualitatively detect human C-reactive protein (CRP) in serum or plasma, a marker used in clinical immunology for assessing inflammation or infection. The test relies on radial immunodiffusion principles, where antigen-antibody interactions form visible precipitation lines proportional to CRP concentration.

The Radial Immuno-Test for Human C-Reactive Protein is supplied as a kit for in vitro diagnostic use in clinical laboratories. It is intended for single-use and requires no special handling beyond standard laboratory procedures. The device received FDA 510(k) clearance (K831958) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) in 1983. No MRI safety or sterility specifications are noted in the regulatory data, and the product is classified as a Class II device under FDA guidelines.

Frequently asked questions

What is the Radial Immuno-Test for Human C-Reactive Protein used for?

This device is designed for qualitative detection of human C-reactive protein (CRP) in serum or plasma using radial immunodiffusion. CRP is a clinical marker used to evaluate inflammation or infection, making this test valuable in immunology for diagnosing and monitoring such conditions.

How is the Radial Immuno-Test for Human C-Reactive Protein supplied?

The test is supplied as a kit intended for in vitro diagnostic use in clinical laboratories. It includes all necessary components for performing the radial immunodiffusion assay, adhering to standard laboratory procedures. No additional handling beyond typical lab protocols is required.

Is the Radial Immuno-Test for Human C-Reactive Protein single-use or reusable?

The Radial Immuno-Test for Human C-Reactive Protein is intended for single-use only. This ensures accuracy and sterility for each test, as reuse could compromise results or introduce contamination.

What regulatory approval does this device have?

The Radial Immuno-Test for Human C-Reactive Protein received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE) in 1983. The device is classified as a Class II medical device under FDA guidelines.

Are there any special storage requirements for this test kit?

While the regulatory data does not specify unique storage conditions beyond standard laboratory practices, it is recommended to store the kit in a clean, dry environment protected from extreme temperatures and direct light to maintain its integrity and performance.

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: RADIAL IMMUNO-TEST FOR HUMAN C-REACTI - Innolitics, RADIAL IMMUNO-TEST FOR HUMAN C-REACTI - Innolitics, RADIAL IMMUNO-TEST FOR HUMAN C-REACTI 510(k) K831958 - FDA.report, FDA Browser - Cleared 510 (K) - RADIAL IMMUNO-TEST FOR HUMAN C-REACTI ..., Product Info - Radial Immunodiffusion Kits | Kent Laboratories

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kent Laboratories, Inc.

Sources (1)

  • FDA 510(k) K831958 24 fields · synced Oct 1, 2026