(58 days)
Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis, and chronic renal disease.
The Wako L-type Fe test is an in vitro diagnostic assay for the quantitative determination of iron in serum. When a sample is mixed with the Buffer, serum protein is denatured by the action of surfactant contained in the Buffer and transferrin-bound iron is liberated. All the Fe" ions released are reduced to Fe2+ by L-ascorbate and form a chelate with bathophenanthroline disulfonic acid disodium salt. The serum iron can be determined by measuring the absorbance of the red chelate solution.
The provided text describes the Wako L-type Fe test, an in vitro diagnostic assay for the quantitative determination of iron in serum. The document states that the safety and effectiveness of this new assay are demonstrated by its substantial equivalency to the Wako Fe B test.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalency | Demonstrated by substantial equivalency to the Wako Fe B test. (No specific thresholds or metrics for equivalency are given beyond this statement.) |
| Precision | "Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific coefficients of variation or standard deviations are provided.) |
| Minimum Detectable Level | "estimated to be 1.2 mg/dL." |
| Linearity | "determined to be linear to 1000 mg/dL." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the study relies on substantial equivalency to a predicate device and not expert-established ground truth for a test set.
4. Adjudication method for the test set:
- Not applicable as the study relies on substantial equivalency to a predicate device and not independent 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 in vitro diagnostic device, not an AI-assisted imaging or diagnostic tool relying on human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device described is an in vitro diagnostic assay, meaning it's a lab test. Its performance is inherent to the chemical reaction and measurement process, not an algorithm that operates independently in a standalone fashion like a software device. The "algorithm" in this context is the chemical method itself. The reported performance metrics (precision, linearity, minimum detectable level) are intrinsic to this chemical "algorithm."
7. The type of ground truth used:
- For the Wako L-type Fe test, the "ground truth" for demonstrating its effectiveness is primarily based on comparison to a legally marketed predicate device (Wako Fe B test), and its ability to accurately measure iron concentrations using its described chemical method (bathophenanthroline as a chromogen). The document does not mention external pathology or outcomes data as the ground truth for the device's validation.
8. The sample size for the training set:
- Not applicable. This is an in vitro diagnostic device and does not involve machine learning models requiring training sets.
9. How the ground truth for the training set was established:
- Not applicable. This is an in vitro diagnostic device and does not involve machine learning models requiring training sets.
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(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.