(414 days)
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.
| Acceptance Criteria (Implied / Comparison Target) | Reported Device Performance (VIDAS® TNIU) | Predicate Device Performance (Dimension RxL® CTNI) |
|---|---|---|
| Expected Values (Healthy Patients) | 99% of 747 patients with no cardiac symptoms had values of |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.