The Parathyroid Hormone (PTH) Test measures the levels of parathyroid hormone in the blood. This hormone is produced by the parathyroid glands, which are located in the neck and help regulate calcium, phosphorus, and vitamin D levels in the body.

Intended use of Parathyroid Hormone Test System

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.

Intended Use:

immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. This assay can be used intraoperatively.

Device Description:

The system processes patient samples (serum or plasma) and prepares them for the sandwich immunoassay format. The reagents, including monoclonal antibodies and microparticles, are added to the samples, and the system performs the reactions necessary for PTH detection.  After the reactions are completed, the system detects the electrochemiluminescence emitted by the ruthenium complex. This light emission is proportional to the amount of intact PTH present in the sample, which is then quantified based on the calibration curve. The system automatically generates and outputs the results, providing the concentration of PTH in the patient’s sample.

Performance Testing (Analytical) for Parathyroid Hormone Test System

• Precision/Reproducibility
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross-Reactivity)

Clinical Testing:

No Guidance available for 510k submission