CRPEX-HS CRP Calibrator Set, Catalog No. 1510

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K021882 ↗

FDA Product Code

DCN

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 primary purpose of the CRPEX-HS CRP Calibrator Set, and how does it contribute to diagnostic accuracy in immunology testing?

  The CRPEX-HS CRP Calibrator Set (Catalog No. 1510) is designed as a reference standard for calibrating immunoassay procedures that measure C-reactive protein (CRP) in serum samples. By providing a precise, standardized calibrator, it ensures accurate and reliable quantification of CRP levels, which is critical for diagnosing inflammation, infections, or autoimmune conditions in immunology diagnostics.

• Is this calibrator set sterile, and if not, what precautions should be taken during handling?

  The CRPEX-HS CRP Calibrator Set is non-sterile, meaning it is not intended for direct patient use or sterile procedures. Since it is a single-use item, standard laboratory aseptic techniques should be followed during preparation and handling to prevent contamination of the calibrator or test samples.

• How should the CRPEX-HS CRP Calibrator Set be stored, and are there any special considerations for its shelf life?

  Storage follows standard laboratory protocols for calibrators, though specific conditions (e.g., temperature, light exposure) are not detailed in the provided data. Since it is a single-use item, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Always verify the manufacturer’s instructions for exact storage guidelines.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  The CRPEX-HS CRP Calibrator Set received FDA 510(k) clearance (K021882) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II in vitro diagnostic device (regulated under 866.5270) for quantitative CRP measurement in immunology diagnostics. Clinicians can rely on its compliance with FDA requirements for accurate calibration in immunoassay procedures.

• Are there multiple sizes or models available for this calibrator set, or is it a single standardized product?

  The provided data does not specify multiple sizes or models for the CRPEX-HS CRP Calibrator Set (Catalog No. 1510). It is described as a single standardized product intended for general use in CRP calibration across immunoassay systems. If specific concentrations or formats are required, the manufacturer’s documentation should be consulted.