(108 days)
The LIAISON® N-tact™ PTH Assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
The LIAISON® N-tact™ PTH Control Set is intended for use as an assayed quality control sample to monitor the accuracy and precision of the DiaSorin LIAISON® N-tact™ PTH immunoassay.
The method for quantitative determination of PTH is a direct, two site, sandwich type chemiluminescence immunoassay (CLIA). Affinity-purified antibody to the 39-84 amino acid sequence of PTH is coated to the solid phase. The second affinity-purified antibody to the 1-34 region is conjugated to an isoluminol derivative. During the incubation, PTH binds to the solid phase, and is subsequently bound by the isolumino! conjugated antibody. After the incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of PTH present in calibrators, controls, or samples.
Here's an analysis of the DiaSorin LIAISON® N-tact™ PTH 510(k) Premarket Notification based on the provided text, focusing on acceptance criteria and study details:
The provided document describes a diagnostic device (immunoassay) for quantitative determination of human parathyroid hormone (PTH), not a device that involves AI or human-in-the-loop performance. Therefore, several sections of your request (e.g., number of experts, adjudication method, MRMC study, human readers, standalone performance, training set details) are not applicable to this type of device and study. The "acceptance criteria" here refer to analytical performance specifications for the assay.
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity (Analytical) | Not explicitly stated, but "high sensitivity" is a general goal. | 1.0 pg/mL (determined from 3 lots, ≤ 1.0 pg/mL for all lots) |
| Sensitivity (Functional) | %CV |
§ 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.