(72 days)
The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum. The TIBC assay is a clinical chemistry assay which involves a sample pretreatment followed by the analysis of TIBC with the Iron reagents. Ferric chloride saturating solution is mixed with the sample to bind all available apotransferrin binding sites with iron. Alumina adsorbent removes excess iron from the mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution by the saturating solution.
Here's an analysis of the provided 510(k) summary regarding the TIBC assay, detailing acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are established by demonstrating substantial equivalence to the predicate device, the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System. The primary performance metrics used for comparison are correlation coefficient, slope, and Y-intercept from a method comparison study, along with precision and linearity data.
| Acceptance Criteria / Performance Metric | Reported Device Performance (TIBC assay) |
|---|---|
| Method Comparison (vs. A-GENT® TIBC assay) | |
| Correlation Coefficient | 0.9896 |
| Slope | 0.988 |
| Y-intercept | 6.790 ug/dL |
| Precision (Total %CV) | |
| Level 1/Panel 111 | 2.1% |
| Level 2/Panel 112 | 4.3% |
| Linearity (Iron assay) | Up to 1778.5 ug/dL |
| Limit of Quantitation (Sensitivity - Iron assay) | 3.8 ug/dL |
| Calculated TIBC values acceptability range | 11.4 ug/dL to 5335.5 ug/dL |
The document states that "These data demonstrate that the performance of the TIBC assay is substantially equivalent to the performance of the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System." This implies that the reported performance metrics met the internal acceptance thresholds for substantial equivalence to the predicate.
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided summary for the method comparison or precision studies.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The studies were "conducted using the AEROSET™ Analyzer."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker (TIBC). The "ground truth" for the test set would be the results obtained from the predicate device (A-GENT® TIBC assay), which is itself a laboratory assay. Expert consensus or human reader interpretation is not typically involved in establishing ground truth for such quantitative chemical assays.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. As an IVD assay comparing results against a predicate assay, there is no human adjudication process involved in generating or confirming the reference values.
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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:
- No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or clinical decision support tool that is interpreted by human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics provided (correlation, precision, linearity, sensitivity) represent the standalone performance of the TIBC assay on the AEROSET™ Analyzer. This is typical for IVD submissions, where the assay itself is the "algorithm" and its performance is evaluated directly.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Predicate Device Results: The "ground truth" for the comparative performance study was the quantitative results obtained from the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System. This is a common and accepted method for establishing substantial equivalence for new IVD assays.
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The sample size for the training set:
- Not applicable/Not mentioned. This device is a traditional chemical assay, not an AI/machine learning model that requires a training set in the conventional sense. The "development" of the assay involves optimization of reagents and procedures, not a data-driven training process with labeled data.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.