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The "Wiener lab. Fer-Color AA" iron test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of 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, and 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.
End point method. Serum iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in the presence of a reducing agent (ascorbic acid). Then it reacts with the color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.
The document describes the Wiener Lab. FER-COLOR AA test system, a photometric method for iron determination, and its equivalence to the RANDOX IRON test system for FDA 510(k) clearance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison between the Wiener Lab. FER-COLOR AA test system and the RANDOX IRON test system, which serves as the predicate device. The "acceptance criteria" are implicitly set by the performance of the predicate device, as the submission aims to demonstrate substantial equivalence.
| Performance Characteristic | Acceptance Criteria (RANDOX Test System) | Reported Device Performance (WIENER LAB. Test System) |
|---|---|---|
| Intended Use | Quantitative determination of iron in human serum and plasma | Quantitative determination of iron in human serum and plasma |
| Test Principle | End point method using ferrozine, measured at 540/580 nm | End point method using ferrozine, measured at 570 nm |
| Essential Components | Buffer acetate - Ascorbic acid - Ferrozine | Buffer acetate - Ascorbic acid - Ferrozine |
| Reagents | R1: Buffer acetate; R2: Ascorbic acid - Ferrozine | R1: Ferrozine; R2: Buffer acetate; R3: Ascorbic acid (reductor) |
| Preparation of Working Reagent | R1 and R2 ready to use | Preparation of Buffer/Reductor |
| Instability or deterioration of reagents | Not specified | Change in Blank and/or Standard Absorbances |
| Sample | Serum and plasma | Serum and plasma |
| Working Temperature Range | 25 - 37°C | 25 - 37°C |
| Stability of final color | Not specified | 5 to 60 minutes |
| Wavelength of reading | 540 - 580 nm | 570 nm |
| Linearity | 1000 µg/dl | 1000 µg/dl |
| Minimum detection limit | Not specified (predicate) | 6.1 µg/dl |
| Expected values | Male: 10.6 – 28.3 µmol/l (59-158 µg/dl); Female: 6.6 – 26.0 µmol/l (37-145 µg/dl) | 60 - 160 µg/dl |
| Intra-assay precision | Level 1: CV = 2.93%; Level 2: CV = 2.29% | Normal Serum Control: CV = 1.32%; Abnormal Serum Control: CV = 0.54% |
| Inter-assay precision | Not specified | Normal Serum Control: CV = 1.75%; Abnormal Serum Control: CV = 1.25% |
Note: The acceptance criteria are largely implied by demonstrating performance comparable to the predicate device. For some parameters, the predicate did not specify a value (e.g., minimum detection limit, inter-assay precision), allowing the applicant to establish their own performance and still claim substantial equivalence if reasonable.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set (i.e., for the precision and comparison studies) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples). The precision data (intra-assay and inter-assay) refers to "Normal Serum Control" and "Abnormal Serum Control," but the number of samples or runs is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For in vitro diagnostic tests like this, ground truth is typically established through analytical methods and reference materials, not expert consensus on interpretations.
4. Adjudication method for the test set
This information is not applicable/provided as the study is a comparison of analytical performance of an in vitro diagnostic device, not a subjective interpretation task requiring 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
An MRMC study was not done. This type of study is relevant for imaging or interpretation devices where human readers are involved. The FER-COLOR AA is an in vitro diagnostic assay, an automated photometric method, and does not involve human readers for interpretation in this context. It is an "algorithm only" device for the measurement of iron concentration.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire submission focuses on the analytical performance of the "WIENER LAB. FER-COLOR AA" test system itself, demonstrating its precision, linearity, and other analytical characteristics in comparison to a predicate device. This is the definition of a standalone study for this type of device.
7. The type of ground truth used
The ground truth for parameters like linearity, minimum detection limit, and expected values would be based on:
- Reference materials/calibrators: For linearity, known concentrations of iron would be used.
- Assigned values: Control materials ("Normal Serum Control," "Abnormal Serum Control") used for precision studies would have assigned target values.
- Clinical studies/population data: "Expected values" are generally derived from studies on healthy populations.
The document does not explicitly state the specific ground truth methodologies in detail but implies these standard practices for IVD assays.
8. The sample size for the training set
This information is not applicable/provided. The FER-COLOR AA is a chemical assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and photometric measurement, not a learned model from data.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.