(83 days)
The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in 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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay." This document primarily focuses on the regulatory clearance process and does not contain specific details about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert ground truth establishment, or similar scientific study details typically found in a clinical trial report or scientific publication.
Therefore, I cannot provide the requested information based on the given text. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it doesn't describe the studies that led to that determination in the detail you're asking for.
To answer your questions, I would need access to the actual 510(k) submission document or a detailed performance study report for the device.
§ 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.