(266 days)
Immunoassay for the in vitro quantitation of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. This assay can be used intraoperatively. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers
Both the Elecsys PTH and Elecsys PTH STAT immunoassays make use of a sandwich test principle using a biotinylated monoclonal PTH-specific antibody labeled with a ruthenium complex. Both the Elecsys PTH and Elecsys PTH STAT immunoassays are intended for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. These assays can be used intraoperatively. They are intended for use on the cobas e immunoassay analyzers.
Results are determined via a calibration curve which is instrument-specifically generated by a two-point calibration and a master curve provided via the reagent barcode.
The reagent working solutions include: Rack Pack (kit placed on the analyzer)
- M Streptavidin coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin . coated microparticles 0.72 mg/mL; preservative.
- . R1 Anti PTH Ab~biotin (gray cap), 1 bottle, 7 mL: Biotinylated monoclonal anti PTH antibody (mouse) 2.3 mg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.
- . R2 Anti PTH Ab~Ru(bpy) (black cap), 1 bottle, 7 mL: Monoclonal anti PTH antibody (mouse) labeled with ruthenium complex 2.0 mg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.
Unfortunately, the provided text does not describe a study involving an AI/Machine Learning powered medical device, nor does it contain information about typical acceptance criteria for such devices (e.g., sensitivity, specificity, AUC).
Instead, the document details a 510(k) premarket notification for Elecsys PTH and Elecsys PTH STAT, which are immunoassays for quantitative determination of intact parathyroid hormone. These are laboratory diagnostic tests, not AI-powered devices.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K070709) by:
- Comparing technological characteristics (Table 1 and Table 2).
- Providing non-clinical performance evaluations such as precision, analytical sensitivity (Limit of Blank, Limit of Detection, Limit of Quantitation), linearity, high dose hook effect, interference studies, and sample matrix comparison.
- Presenting a method comparison to the predicate devices.
- Reporting on stability and a reference range study.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets acceptance criteria based on this input. The information required for your questions (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are specific to AI/ML device evaluations and are not present in this document about an immunoassay.
§ 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.