(134 days)
For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use.
Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the Calcium ADVANCE Assay. It acknowledges the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
The information you are asking for, such as specific acceptance criteria for performance, sample sizes used in testing, details about ground truth establishment, or information about MRMC studies, would typically be found in the actual 510(k) submission document itself, which is often a large technical file not publicly released in its entirety in this format. The letter only states that the device is deemed "substantially equivalent" for the stated indications of use.
Therefore, I cannot provide the requested information based on the text provided.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.