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VIDAS® Troponin I Ultra is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma (lithium heparin) using the ELFA (Enzymc-Linked Fluorescent Assay) technique. VIDAS Troponin I Ultra is intended to be used as an aid in the diagnosis of myocardial infarction.

The VIDAS Troponin I Ultra (TNIU) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS® instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are in the sealed TNIU Reagent Strips. The sample is transferred into the wells containing anti-cardiac troponin i antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR for a specified length of time. Troponin I present in the specimen will bind to the anticardiac troponin i immunoglobulin coating the interior of the SPR. Unbound sample components are washed away. A fluorescent substrate, 4-methylumbellifery| phosphate, is introduced into the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The optical scanner in the instrument measures the intensity of fluorescence. When the VIDAS TNIU assay is completed, the results are analyzed automatically by the computer, a test value is generated, and a report is printed for each sample.

Here's a breakdown of the acceptance criteria and study information for the VIDAS® Troponin I Ultra (TNIU) Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical targets. Instead, it presents performance data for both the VIDAS® TNIU and the predicate device (Dimension RxL® CTNI) for comparison, implying that similar or improved performance relative to the predicate device is the goal for most parameters, and certain established clinical cut-offs are considered.

Given this, I've constructed a table focusing on the performance characteristics that were measured and compared, as these implicitly serve as the basis for demonstrating substantial equivalence.

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