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 assay is for in vitro diagnostic use in the quantitative measurement of calcitonin in human serum. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

Device Description: The system is an advanced immunoassay device specifically designed to measure the concentration of calcitonin in patient blood samples. It employs various immunoassay methodologies, which is highly sensitive and accurate, making it an ideal tool for detecting even low levels of calcitonin. This sensitivity is crucial for diagnosing thyroid-related conditions, particularly medullary thyroid cancer (MTC), and for monitoring conditions like hypercalcemia and patients recovering from thyroid surgery. The system operates with a combination of reagents, sample collection tools, and an automated analyzer that facilitates the accurate measurement of calcitonin levels. The reagents used in the system enable the immunoassay reaction, where antibodies bind specifically to calcitonin in the blood sample

• Limit of Blank (LoB),
• Limit of Detection (LoD),
• Limit of Quantitation (LoQ)
• Linearity

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking