(120 days)
The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin 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. This assay is intended for in vitro diagnostic use only.
Calcitonin ELISA Test Kit
This document is a 510(k) clearance letter from the FDA for a Calcitonin ELISA Test Kit. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study from the provided input.
§ 862.1140 Calcitonin test system.
(a)
Identification. 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).(b)
Classification. Class II.