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510(k) Data Aggregation
(117 days)
The N Latex sTfR Reagent is an in vitro diagnostic reagent for the quantitative determination of sTfR in human serum or heparinized plasma using the Behring Nephelometer Systems (BNA, BN100, & BNII), and aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
N Latex sTfR Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of soluble transferrin receptor (sTfR) in human serum or heparinized human plasma.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Inc. N Latex sTfR Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the N Latex sTfR Reagent primarily focuses on establishing substantial equivalence to a predicate device rather than defining new, explicit acceptance criteria in the traditional sense. The performance characteristics described are used to demonstrate that the device performs comparably to the predicate. Therefore, the "acceptance criteria" can be inferred from what the manufacturer chose to report as sufficient for equivalence.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (N Latex sTfR Reagent) |
|---|---|---|
| Correlation | Strong positive correlation (e.g., r > 0.90) with the predicate device. | r = 0.96 with a commercially available sTfR assay. |
| Slope (Correlation) | Close to 1.0 (indicating similar overall scale). | 0.81 |
| Y-intercept (Correlation) | Close to 0 (indicating similar bias at low concentrations). | -0.19 |
| Inter-assay Precision | Low variability (e.g., < 5% CV). | 0.8% to 1.2% |
| Intra-assay Precision | Low variability (e.g., < 5% CV). | 1.4% to 2.1% |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 62 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involved comparing the N Latex sTfR Reagent to a "commercially available sTfR assay," implying human serum/plasma samples. The type of samples (ranging from 0.41 to 3.5 mg/l) suggests clinical or laboratory-collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For this type of in vitro diagnostic device, "ground truth" for the test set would typically be established by the results from the predicate device (Quantikine IVD human sTfR assay) or a reference method. The text does not mention any expert review of these results for the purpose of establishing ground truth for the comparison.
4. Adjudication Method for the Test Set
This information is not specified in the provided text. Adjudication methods (like 2+1, 3+1) are usually relevant when expert reviewers are determining a diagnosis or outcome from images or complex clinical data. For a quantitative assay comparison, the "ground truth" is typically the measurement from the reference method or predicate, and adjudication in the traditional sense is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging tool. Therefore, a study involving human readers and AI assistance for interpreting results is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The study directly assessed the performance of the N Latex sTfR Reagent itself (the "algorithm only") by comparing its measurements to those of a predicate device and evaluating its precision. This "standalone" assessment of the device's analytical performance is the core of the submission. The "human-in-the-loop" component for this type of device would involve laboratory technicians performing the test and clinicians interpreting the results, but the study itself focuses on the device's inherent measurement capabilities.
7. The Type of Ground Truth Used
The ground truth for the correlation study was established by the measurements obtained from the predicate device (or a "commercially available sTfR assay"). For precision studies, the ground truth refers to the expected value of the control materials and human serum pools used, which would have established ranges or target values based on prior validation.
8. The Sample Size for the Training Set
This information is not provided in the text. This type of device (a reagent for an immunoassay) typically does not involve a "training set" in the machine learning sense. The performance characteristics (correlation, precision) are determined through analytical validation studies, not by training an algorithm on a large dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the machine learning sense for this device, this question is not applicable. The device's formulation and operational parameters would be developed through R&D, and its performance validated through studies like those described, rather than "trained."
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