(448 days)
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDSiSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
The kit is for in vitro diagnostic use only.
The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the precision of the IDS-iSYS Intact PTH assay.
The IDS-iSYS Intact PTH Calibrator is intended for the calibration of the IDS-iSYS Intact PTH assay.
The IDS-iSYS iPTH Calibration Verifier is intended for verification of calibration of the IDS-iSYS iPTH Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
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This document is a 510(k) clearance letter from the FDA for the IDS-iSYS Intact PTH assay. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, device performance data, study details, or ground truth information as requested in your prompt.
The FDA 510(k) clearance letter primarily confirms that the device meets the regulatory requirements for marketing based on substantial equivalence. It refers to a "premarket notification" which would typically include the study data, but that specific document is not provided here.
Therefore, I cannot provide the requested table and study details based solely on the provided text. To answer your prompt, you would need the actual premarket notification submission (510(k) documentation) for K103325, which would contain the study results and acceptance criteria.
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.