C-Reactive Protein (Crp), for Technicon Ra Systems

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863628 ↗

FDA Product Code

DCK

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the CRP Test System for Technicon RA Systems used for?

  The CRP Test System is designed to measure C-reactive protein (CRP) levels in serum and other body fluids. CRP is a blood protein that increases in response to inflammation, infection, or tissue injury, making this system useful for evaluating inflammatory conditions in immunology-related diagnostic assessments.

• How is the CRP Test System supplied, and what type of analyzer does it require?

  The CRP Test System is supplied as a reagent kit exclusively for use with Technicon RA Systems, a legacy automated immunoassay analyzer. It is not compatible with other analyzers and must be used within the intended system for accurate results.

• Is the CRP Test System sterile, and is it intended for single-use?

  The reagents in the CRP Test System are non-sterile and are intended for single-use in laboratory settings. Proper handling and storage are required to maintain the integrity of the reagents and ensure accurate test outcomes.

• What regulatory classification does the CRP Test System hold, and what is its clearance status?

  The CRP Test System is classified as a Class II medical device under FDA regulation 866.5270. It holds a 510(k) clearance (K863628) with a decision of Substantially Equivalent (SESE), indicating it meets FDA standards for safety and effectiveness.

• Are there any special storage or handling requirements for the CRP Test System?

  Storage and handling of the CRP Test System must follow the manufacturer’s guidelines to preserve reagent stability and ensure accurate diagnostic results. Since the reagents are non-sterile and single-use, they should be stored in a controlled environment, protected from contamination and extreme temperatures.