(67 days)
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
AxSYM® I PTH is based on the Microparticle Enzyme Immunoassay (MEIA) technology. The AxSYM® I PTH assay uses paired monoclonal and polyclonal antibodies, each reactive with epitopes in the N-terminal portion of intact human PTH (1-84). The polyclonal antibody is biotin labeled. I PTH in the sample serves to bridge the two antibodies.
The provided text does not contain a study that proves the acceptance criteria of the device. Instead, it details the substantial equivalence of the "AxSYM Intact PTH" device to a predicate device, the "DSL-8000 ACTIVE™ Intact PTH IRMA," through method correlation and comparison of various performance characteristics.
Therefore, the following points address the questions based on the information available regarding the substantial equivalence study, rather than a study specifically proving acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this context are not explicitly stated numerical targets for device performance, but rather the demonstration of "substantial equivalence" to a predicate device. This is primarily shown through method correlation and comparable performance characteristics.
| Feature | Acceptance Criteria (Implied by Predicate Performance / Substantial Equivalence Goal) | Reported AxSYM® I PTH Performance |
|---|---|---|
| Method Correlation | Very high correlation (r value close to 1) between AxSYM® I PTH and predicate device. | r = 0.97 (p |
§ 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.