(82 days)
VIDAS Troponin I Assay is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin 1 in serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique
The VIDAS Troponin I (TNI) 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 TNI 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 anti-cardiac troponin I immunoglobulin coating the interior of the SPR. Unbound sample components are washed away.
A fluorescent substrate, 4-methylumbelliferyl 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 TNI 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 details for the VIDAS Troponin I (TNI) Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined column. Instead, it presents performance data for both the VIDAS TNI assay and its predicate device, the Stratus CS Cardiac Troponin I Testpak, implying that the VIDAS TNI assay needed to demonstrate comparable performance to the predicate. The "Reported Device Performance" column reflects the performance of the VIDAS TNI assay.
| Performance Characteristic | Predicate Device (SCS cTnl) Performance | VIDAS TNI Assay Performance |
|---|---|---|
| Nonclinical Testing | ||
| Within-run precision (% CV) | 2.7 - 4.3 | 1.3 - 2.5 |
| Dilution % Recovery | 98.1 - 102.0 | 97 - 111 |
| Analytical Sensitivity | 0.03 µg/l |
§ 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.