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The IDS iSYS 25-Hydroxy Vitamin DS Assay (IDS-iSYS 250HD*) is intended for the quantitative determination of 25-hydroxyvitamin D (25OHD) and other hydroxylated metabolites in human serum on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The IDS-iSYS 25-Hydroxy Vitamin DS (250HDS) Control Set is used for quality control of the IDSiSYS 25-Hydroxy Vitamin DS assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS 25-Hydroxy Vitamin DS assay consists of a reagent cartridge and one set of calibrators (Calibrators A & B or CAL A & CAL B). The reagent cartridge contains multiple reagents: MPV1 (Magnetic particles coated with 25-OH D in a phosphate buffer containing methanol with sodium azide as preservative), CONJ (Anti- 25-OH D sheep polyclonal antibody labelled with an acridinium ester derivative, in buffer containing bovine, sheep, rabbit and mouse proteins with sodium azide as preservative), NaOH (Sodium hydroxide solution

This is an analysis of a 510(k) summary for the IDS-iSYS 25-Hydroxy Vitamin Dˢ Assay and IDS-iSYS 25-Hydroxy Vitamin Dˢ Control Set.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by internal specifications of the manufacturer, often guided by CLSI (Clinical and Laboratory Standards Institute) guidelines or regulatory precedents. The document presents the reported performance without explicitly stating pre-defined acceptance criteria for each measurement, but rather implies acceptability by presenting results typically expected for such assays. For some sections, such as precision/reproducibility and interference, the acceptable range is mentioned within the text (e.g., ±10% bias for interference).

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