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C-Reactive Protein Kit for Use on SPAPLUS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161982

by The Binding Site Group

Identifiers

510(k) Number
K161982 FDA 510(k)
FDA Product Code
DCN 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 C-Reactive Protein Kit is an in vitro diagnostic system designed for the quantitative determination of C-reactive protein (CRP) concentration in serum. CRP is a biomarker used to assess tissue injury, infection, and inflammatory responses, aiding clinical evaluation of these conditions. Classified under product code DCN as a System, Test, C-Reactive Protein, this device operates within Class II regulatory controls.

This kit is intended for laboratory use and is supplied as a single-use diagnostic tool. It is not MRI-compatible and requires adherence to standard in vitro diagnostic sterility and handling protocols. The device is authorized under FDA 510(k) clearance (K161982) and falls under the jurisdiction of the Immunology advisory committee. Storage and usage must comply with manufacturer guidelines to ensure accurate and reliable CRP measurement.

Frequently asked questions

What is the C-Reactive Protein Kit for use on SPAPLUS designed for?

The C-Reactive Protein Kit is an in vitro diagnostic system specifically designed for the quantitative determination of C-reactive protein (CRP) concentrations in serum. CRP is a biomarker used to evaluate tissue injury, infection, and inflammatory responses, helping clinicians assess these conditions during patient evaluation.

How is the C-Reactive Protein Kit supplied, and is it single-use?

The kit is supplied as a single-use diagnostic tool, meaning each kit is intended for one-time use only. This design ensures sterility and accuracy per manufacturer guidelines, preventing cross-contamination and maintaining reliable results.

Is the C-Reactive Protein Kit sterile, and how should it be handled?

Yes, the kit adheres to standard in vitro diagnostic sterility protocols. It must be handled according to the manufacturer’s instructions to preserve sterility and ensure accurate CRP measurements. Improper handling could compromise results or introduce contamination.

What regulatory pathway does the C-Reactive Protein Kit follow?

The kit is authorized under FDA 510(k) clearance (K161982) and is classified under product code DCN as a System, Test, C-Reactive Protein. It falls under Class II regulatory controls and is reviewed by the Immunology advisory committee.

Can the C-Reactive Protein Kit be used with MRI or other imaging modalities?

No, the kit is not MRI-compatible. It is designed exclusively for laboratory use with the SPAPLUS system and should not be used in conjunction with MRI or other imaging equipment.

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: C-Reactive Protein Kit for use on SPAPLUS - fda.innolitics.com, K161982 FDA 510(k) - C-Reactive Protein Kit for use on SPAPLUS, PDF C-Reactive Protein Kit For Use On SPAPLUS 510(k)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
The Binding Site Group

Sources (1)

  • FDA 510(k) K161982 24 fields · synced Oct 1, 2026