(20 days)
CANTROL Serum Iron and Total Iron Binding Capacity test system provides a simple, but effective, method for quantitating the level of serum iron and total iron binding capacity in human blood serum.
In the CANTROL Serum Iron procedure Iron is released from its carner, transferrin, by an acidic reagent containing hydroxylamine and thiourea which reduces the iron to its ferrous state. A chromogen reagent, ferene, reacts with the ferrous iron to produce a colored complex, the color of which is proportional to the quantity of Iron in the test sample. Color of the reaction is measured spectrophotometrically.
Total Iron Binding Capacity analysis uses the same color reaction to test serum samples which have been saturated with iron by use of an ion exchange resin in the presence of ferric ammonium citrate, prior to the iron determination. The bound iron remaining in the serum after treatment with the resin compound is the Total Iron Binding Capacity.
This document is a 510(k) submission summary for "CANTROL Serum Iron and Total Iron Binding Capacity test system." It describes a laboratory assay for measuring serum iron and total iron binding capacity in human blood serum. The information provided is about the chemical principles of the assay and claims of performance, but it does not contain details about acceptance criteria or a study that rigorously proves the device meets those criteria in a modern sense.
Here's a breakdown based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Study Details for CANTROL Serum Iron and Total Iron Binding Capacity Test System
The provided 510(k) submission summary primarily describes the methodology of the CANTROL Serum Iron and Total Iron Binding Capacity test system and generally references "Precision, Linearity and Correlation data" as submitted to demonstrate product performance. However, it does not explicitly state specific numerical acceptance criteria (e.g., a target precision value or a correlation coefficient threshold) or provide detailed results from a formal study proving these criteria were met.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Not explicitly stated as numerical targets. Implied criteria relate to "Precision, Linearity and Correlation" to demonstrate "substantial equivalency with another legally marketed predicate device." | "Precision, Linearity and Correlation data is submitted to demonstrate product performance and substantial equivalency with another legally marketed predicate device." |
Note: The document states that "Precision, Linearity and Correlation data is submitted," implying that these data were part of the full 510(k) submission, but the summary itself does not provide the specific numerical results or the acceptance thresholds used.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided summary. The data would presumably be from human blood serum samples, but details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in the context of this device. The CANTROL system is a laboratory assay for measuring specific analytes (serum iron and TIBC). The "ground truth" for such devices is established by reference methods or validated comparative methods, not by human expert consensus or interpretation of images/data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., radiology images) is involved to establish a ground truth. For a chemical assay, the "adjudication" would relate to laboratory quality control measures and comparison to established reference standards or predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are used for devices that involve human interpretation, such as diagnostic imaging AI. This device is a quantitative chemical assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone laboratory assay. Its performance is evaluated intrinsically through its chemical measurement capabilities without a "human-in-the-loop" in the sense of interpreting its output to arrive at a diagnosis. The assay simply produces a numerical result. The "performance" assessment would relate to its analytical accuracy, precision, linearity, and correlation with a predicate device. The summary implies this standalone performance was evaluated and submitted.
7. The Type of Ground Truth Used
For this type of device, the "ground truth" would be established by:
- Validated Reference Methods: Highly accurate and precise laboratory methods considered the gold standard for measuring serum iron and TIBC.
- Comparison to a Legally Marketed Predicate Device: The summary explicitly states the data demonstrates "substantial equivalency with another legally marketed predicate device," which serves as the comparative "ground truth" for regulatory purposes.
8. The Sample Size for the Training Set
Not applicable. This is a traditional chemical assay kit, not a machine learning or AI-based device that requires a "training set" in the computational sense. The "training" of such a system involves developing the chemical reagents and procedures, which is based on established biochemical principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML context. The development and validation of the chemical components and procedures would rely on established scientific principles and analytical chemistry validation practices.
§ 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.