(42 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 is used in the pretreatment of serum samples for total iron binding capacity analysis with the Iron assay. 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 serum mixture. The mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution of the serum by the saturating solution.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new Abbott Laboratories TIBC assay are implicitly defined by its substantial equivalence to the predicate device, the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer. The performance metrics reported are primarily related to this comparison.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Abbott TIBC assay) |
|---|---|
| Correlation with Predicate Device: Acceptable correlation (typically r > 0.95 or similar for quantitative assays) | Correlation coefficient (r) = 0.9863 |
| Slope of Regression (vs. Predicate): Close to 1 (indicating proportional agreement) | Slope = 0.878 |
| Y-intercept of Regression (vs. Predicate): Close to 0 (indicating absence of systematic bias) | Y-intercept = 36.71 ug/dL |
| Precision (Within-run, Between-run, Between-day): Acceptable variability (e.g., CV% limits) | Total %CV for Level 1/Panel 111 = 4.0% |
| Total %CV for Level 2/Panel 112 = 4.9% | |
| Linearity: Up to a specified high concentration | Linear up to 1,400 ug/dL (for the Iron assay, which is part of the TIBC determination) |
| Limit of Quantitation (Sensitivity): A specified low concentration | 10 ug/dL (for the Iron assay) |
| Acceptable Measurement Range for TIBC: A specified range where results are valid | 30 ug/dL to 4,200 ug/dL |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the comparative performance studies (method comparison). It mentions "comparative performance studies were conducted" and "precision studies were conducted using two levels of control material."
- Sample Size: Not specified for the method comparison or precision studies.
- Data Provenance: Not specified. It's likely retrospective data from laboratory samples, but no country of origin or specific type of samples (e.g., patient samples, spiked samples) is provided. The use of "control material" for precision studies suggests commercially prepared controls.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and is not provided in the document. The study evaluates a quantitative in vitro diagnostic assay, where "ground truth" for individual measurements is established by the reference measurement procedure (the predicate device) or by known concentrations in control materials, not by expert consensus in the way a diagnostic imaging or pathology study might use.
4. Adjudication Method (for the test set)
Not applicable. As described above, this is a quantitative measurement comparison, not a study requiring adjudication of qualitative or subjective interpretations.
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 in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance study describes the standalone performance of the Abbott TIBC assay (which is an enzymatic/colorimetric chemical assay, not an algorithm in the modern AI sense, but functions as a standalone test). The method comparison and precision studies demonstrate the performance of the device without human interpretation or intervention in the measurement process beyond standard laboratory operating procedures.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Reference Method/Predicate Device: For the comparative performance, the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer served as the reference or benchmark method.
- Known Concentrations: For precision studies, "control material" at two levels (Level 1/Panel 111 and Level 2/Panel 112) would have known or target concentrations against which the variability of the device's measurements are assessed.
- Spiked Samples/Standards: For linearity and sensitivity, known concentrations of iron would be used to establish the quantitative range and detection limits.
8. The Sample Size for the Training Set
Not applicable. This is a traditional in vitro diagnostic chemical assay, not a machine learning or AI device that requires a "training set." The assay itself is based on established chemical reactions.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.