(113 days)
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum on the Dimension Vista ™ System. Measurements of cardiac troponin I are used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-1 (CTNI) on the Dimension Vista™ system.
For use on the Dimension Vista™ System to dilute samples with elevated CTNI results.
The CTNI method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated anti-cardiac troponin I monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-cardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/cardiac troponin I/biotinylated antibody sandwich. Sensibeads then are added and bind to the biotin to form beadaggregated immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses into the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample.
The Dade Behring CTNI Calibrator is a three level frozen liquid product (levels A, B, C) containing human troponin complex in a human serum matrix with stabilizers and preservative. The kit contains 3 vials of each level (A= 2.0 mL, B= 1.0 mL, C= 1.5 mL).
The Dimension Vista™ CTNI SDIL Sample Diluent is a single level liquid product containing a human serum matrix with stabilizers and preservative. The kit contains 6 vials with 2.5 mL in each vial.
This document describes the safety and effectiveness of the Dimension Vista™ CTNI Flex® reagent cartridge, Dimension Vista™ CTNI Calibrator, and Dimension Vista™ CTNI SDIL Sample Diluent. The device is intended for the quantitative measurement of cardiac troponin I in human serum to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is primarily demonstrated through a comparison to a predicate device (Dade Behring Dimension® CTNI). The acceptance criteria are implicitly established by showing "good agreement" and "substantially equivalent" performance to the predicate device in various analytical aspects.
| Acceptance Criteria (Implicit - based on predicate device performance) | Reported Device Performance (Dimension Vista™ CTNI) |
|---|---|
| Intended Use | Quantitative measurement of cardiac Troponin I in human serum; aid in diagnosis of AMI and risk stratification of acute coronary syndromes. |
| Assay Type | Chemiluminescent immunoassay |
| Reportable Range | 0.015 to 40 ng/mL |
| Analytical Sensitivity | 0.015 ng/mL |
| Functional Sensitivity | 0.04 ng/mL |
| Analytical Specificity (Cross-reactivity at 1000 ng/mL) | Skeletal muscle troponin-I: 0.12 ng/mL |
| Cardiac troponin -T: 0.06 ng/mL | |
| Cardiac troponin-C: 0 ng/mL | |
| Interferences (No significant interference from) | Bilirubin, conjugated up to 40 mg/dL |
| Bilirubin, unconjugated up to 40 mg/dL | |
| Hemoglobin up to 500 mg/dL | |
| Triglycerides up to 3000 mg/dL | |
| Hook Effect | No high dose effect up to 1000 ng/mL |
| Calibration Interval | Calibration curve updated for each lot, using six levels every 30 days with the same reagent lot. |
| Sample Volume | 20 uL |
| Method Comparison (Correlation with predicate device) | Slope: 1.015 |
| Intercept: -0.003 ng/mL | |
| Correlation Coefficient: 0.993 | |
| Reproducibility (%CV) | Repeatability (Within-run): |
| Level 1 (0.123 ng/mL): 4.21% | |
| Level 2 (0.55 ng/mL): 2.28% | |
| Level 3 (24.51 ng/mL): 4.13% | |
| Level 4 (31.41 ng/mL): 3.0% | |
| Within Lab (Total CV): | |
| Level 1 (0.123 ng/mL): 5.77% | |
| Level 2 (0.55 ng/mL): 2.93% | |
| Level 3 (24.51 ng/mL): 4.60% | |
| Level 4 (31.41 ng/mL): 3.76% |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Test Set:
- Sample Size: 197 serum patient samples.
- Data Provenance: Not explicitly stated, but implied to be human serum patient samples collected for method comparison, likely retrospective, given the use of linear least squares regression analysis on a range of values. The country of origin is not specified.
- Reproducibility Test Set:
- Sample Size: Not explicitly stated as individual patient samples. "Serum Pool" at different levels were used. For each test level, a single test from two independent cups was analyzed twice per day. The guideline CLSI/NCCLS EP5-A2 typically involves multiple runs over several days/weeks.
- Data Provenance: Not specified. Likely laboratory-prepared serum pools.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic test for quantitative measurement and its performance is assessed against a predicate device and analytical targets, not by expert consensus on diagnoses for individual cases.
4. Adjudication Method for the Test Set
Not applicable. The test set involved quantitative measurements and comparison to a predicate device, not qualitative assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (Method Comparison, Reproducibility) represent the standalone performance of the Dimension Vista™ CTNI method. The device provides a quantitative measurement of cardiac troponin I, and its performance is evaluated based on its accuracy, precision, and agreement with a predicate device, without direct human intervention in the measurement process itself beyond standard laboratory procedures.
7. The Type of Ground Truth Used
- Method Comparison: The "ground truth" for the method comparison study was established by the predicate device (Dade Behring Dimension® CTNI immunoassay). The goal was to demonstrate agreement with an already legally marketed and accepted device.
- Reproducibility: The "ground truth" was the expected concentration of cardiac troponin I in the serum pools, against which the device's precision (repeatability and within-lab variability) was assessed. These known concentrations would have been established through a reference method or careful preparation.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. This is an immunoassay, and its development involves reagent optimization and calibration procedures rather than algorithm training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the context of an immunoassay. The development of such a device involves:
- Reagent development and optimization: This involves titrations, interference studies, and ensuring proper antibody binding.
- Calibration: This involves using known standards (calibrators) to establish a standard curve from which unknown sample concentrations are calculated. The calibrators contain a human troponin complex in a human serum matrix with stabilizers and preservatives, with defined concentrations.
§ 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.