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The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy.

The ARCHITECT Cyclosporine Calibration are for the ARCHITECT i System when used for the quantitative determination of cyclosporine in human whole blood.

The ARCHITECT Cyclosporine Whole Blood Precipitation Reagent is for the extraction of cyclosporine from samples (human whole blood patient specimens, controls, and ARCHITECT Cyclosporine Calibrators) to be tested on the ARCHITECT i System.

The ARCHITECT Cyclosporine assay is a two-step immunoassay for the quantitative determination of cyclosporine in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex.

Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is lysed with a solubilization reagent, extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System.

In the first step, sample, assay diluent, and anti-cyclosporine coated paramagnetic microparticles are combined to create a reaction mixture. Cyclosprorine present in the sample binds to the anti-cyclosporine coated microparticles. After washing, cyclosporine acridiniumlabeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of cyclosporine in the sample and the RLUs detected by the ARCHITECT i System optics.

Here's a breakdown of the acceptance criteria and the studies performed for the ARCHITECT Cyclosporine Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for precision, linearity, functional sensitivity, or analytical sensitivity in numerical terms (e.g., "Precision must be

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