A Calcitonin Test System is a diagnostic tool used to measure calcitonin; a hormone that helps regulate calcium levels in the blood. It is primarily used to diagnose and monitor conditions like medullary thyroid cancer (MTC), hypercalcemia, and other thyroid-related disorders.

A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Intended Use: The device is intended for the quantitative in vitro determination of calcium concentration in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX Daytona plus. Such Measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

Device Description: Azo dyes and their interaction with calcium ions, the context generally refers to a specific class of indicators used in titrimetric analysis or colourimetric assays for detecting calcium ions (Ca²⁺). Azo dyes are synthetic dyes containing one or more azo groups (–N=N–) and are often used as indicators because of their ability to change colour in response to changes in the environment, such as pH or metal ion concentration. zo dye that could be used as an indicator for calcium is Calcein, which is often used in titrations involving calcium. Calcein is an indicator that forms a complex with calcium ions, resulting in a colour change when the calcium ions are bound by a chelating agent like EDTA. The mechanism of azo dyes, like Eriochrome Black T or Calcein, as indicators in calcium determinations is based on their ability to form a complex with calcium ions.

• Before titration: The azo dye forms a coloured complex with calcium ions, typically red or purple.
• During titration: EDTA is added, binding to the calcium ions and releasing the dye. The dye, now free from calcium, changes colour.
• At the endpoint: The colour shifts (e.g., from red to blue), signalling that all calcium ions have reacted with EDTA.

Intended use: The system is intended for use in the in vitro quantification of ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings. Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Device Description: The Ionized calcium is measured by ion selective electrode. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to a reference electrode, this electrical potential is translated into voltage and then into the ion concentration of the sample.

• Precision/Reproducibility
• Linearity/assay reportable range
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Interference

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking