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510(k) Data Aggregation
(181 days)
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction.
For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human heparin plasma.
The Vitros Troponin I assay is performed using the Vitros Troponin I Reagent Pack and Vitros Immunodiagnostic Products Troponin I Calibrators on the Vitros ECi Immunodiagnostic System with Intellicheck ™ . An immunometric technique is used. Cardiac Troponin I present in the sample reacts simultaneously with a biotinylated antibody (mouse monoclonal anti-cTnI) and a horseradish peroxidase (HRP)-labeled antibody conjugate (affinity purified goat polyclonal anti-cTnI). The antigen-antibody complex is captured by streptavidin on the wells. Unbound materials are removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent (a substituted acetanilide) is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the Vitros ECi System. The amount of HRP conjugate bound is directly proportional to the concentration of cTnI present in the sample.
The provided text details a 510(k) submission for the VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators. This document primarily focuses on demonstrating substantial equivalence to a predicate device and presenting performance data related to interference and precision rather than explicitly outlining "acceptance criteria" for a novel device's performance against clinical endpoints.
However, based on the provided information, we can infer some performance expectations and how they are addressed:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
Since this is a 510(k) submission for an in-vitro diagnostic device, the "acceptance criteria" are implicitly tied to demonstrating performance that is equivalent to a legally marketed predicate device and within clinically acceptable ranges for intended use. The document provides data on precision at relevant Troponin I concentrations and potential interference.
| Criteria (Inferred from clinical relevance and typical IVD requirements) | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Precision at Upper Reference Limit (0.08 ng/mL) | Acceptable Coefficient of Variation (CV%) and Standard Deviation (SD) | SD: 0.010 ng/mL, CV%: 12.0% |
| Precision at Lowest Concentration with 10% CV | Achieve 10% CV at a clinically relevant low concentration | Achieve 10% CV at 0.12 ng/mL (SD: 0.012 ng/mL) |
| Precision at AMI Cutoff (0.4 ng/mL) | Acceptable CV% and SD at the clinical cutoff for Myocardial Infarction | SD: 0.024 ng/mL, CV%: 5.9% |
| Hemoglobin Interference (at 0.026 ng/mL cTnI) | Bias within acceptable limits at various hemoglobin concentrations | At 100 mg/dL: 0.043 ng/mL positive bias |
| At 250 mg/dL: 0.175 ng/mL positive bias | ||
| At 500 mg/dL: 0.226 ng/mL positive bias | ||
| Hemoglobin Interference (at ~0.3 ng/mL cTnI) | Bias within acceptable limits at various hemoglobin concentrations | At 100 mg/dL: 0.029 ng/mL positive bias (for 0.279 ng/mL cTnI) |
| At 250 mg/dL: 0.075 ng/mL positive bias (for 0.305 ng/mL cTnI) | ||
| At 500 mg/dL: 0.166 ng/mL positive bias (for 0.347 ng/mL cTnI) | ||
| Substantial Equivalence | Demonstrated equivalence to the DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method (K973650) | The submission explicitly states the device is "substantially equivalent" and provides additional interference and precision data to support this conclusion. |
The study details that evaluate these performance characteristics are described below:
2. Sample Size Used for the Test Set and Data Provenance
-
Precision Study:
- Sample Size: Ten patient sample pools.
- Testing Protocol: Assayed in singleton once per day on 11 different days over a 28-day period using a single reagent lot.
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient sample pools," suggesting human biological samples. The study design (multiple days, single reagent lot) is typical for prospective precision studies. Retrospective vs. Prospective is not explicitly mentioned but implies prospective testing.
-
Hemoglobin Interference Study:
- Sample Size: Not explicitly stated, but measurements were performed at two different "troponin levels" (0.026 ng/mL and approximately 0.3 ng/mL) with varying hemoglobin concentrations.
- Testing Protocol: Replicate determinations were performed using one or two different lots of reagent.
- Data Provenance: Not explicitly stated (e.g., country of origin). The nature implies laboratory testing rather than real-world patient data (prospective testing for interference).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an in-vitro diagnostic (IVD) assay for measuring a biomarker, not an imaging device or a device requiring expert interpretation of results to establish a "ground truth" for the device's output. The "ground truth" for the precision and interference studies would be the known concentration of Troponin I in the spiked samples or the analytical value against which bias is calculated.
4. Adjudication Method for the Test Set
Not applicable. This is an IVD assay, and the outcome is a quantitative measurement, not a subjective interpretation 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 is an IVD assay and does not involve "human readers" or "AI assistance" in the context of interpretation that would necessitate an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is an IVD device, which by its nature, operates in a "standalone" fashion by performing the quantitative measurement. The results are then interpreted by clinicians. The precision and interference studies demonstrate this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance studies is based on:
- Known (nominal) concentrations: For the precision and interference studies, the analyte concentrations (Troponin I and hemoglobin) in the samples or spiked samples serve as the reference or nominal "ground truth" against which the device's measurements, variability, and bias are evaluated.
- Analytical methods/reference materials: The accuracy of these known concentrations would be established using validated analytical methods and potentially reference materials, though the specific methods for establishing the initial sample concentrations are not detailed in this summary.
8. The Sample Size for the Training Set
Not applicable. This device is a biochemical immunoassay, not a machine learning or AI-driven device that requires a "training set" in the computational sense. Its performance is based on chemical reactions and optical detection.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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