(35 days)
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.
The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.
The provided text describes the 510(k) summary for the "quantex Ferritin" device. This is an in vitro diagnostic (IVD) device, not a an Artificial Intelligence/Machine Learning (AI/ML) device that typically involves the concepts of ground truth, experts, and training/test sets in the same way.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not directly applicable or are not detailed in the context of this type of traditional IVD submission. The provided document focuses on establishing substantial equivalence to a predicate device through performance data, primarily method comparison and precision, rather than validating an AI algorithm.
However, I can extract the available information and present it in the requested format, noting where information is not available or not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate Axios Ferritin for quantitative ferritin determination. (Implied: High correlation and acceptable bias.) | 94 serum samples (3.2 to 1000 ng/ml). Slope: 0.92, Correlation Coefficient (r): 0.994 (vs. predicate device). |
| Precision (Within-Run) | Acceptable coefficient of variation (CV) for consistent results. | CV: 4.1% (at mean 43.2 ng/mL) and 1.6% (at mean 402.8 ng/mL) using quantex Ferritin controls I/II. |
| Intended Use | Aid in diagnosis of diseases affecting iron metabolism (hemochromatosis, iron deficiency anemia). | Met (stated as substantially equivalent to predicate). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 94 serum samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is common for traditional IVD submissions which often use internal lab studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For an IVD device measuring a biomarker (ferritin), "ground truth" is typically established by comparative measurement against a reference method or predicate device, not by expert interpretation in the way it's used for AI/ML image analysis. The "ground truth" here is the measurement obtained from the predicate device.
4. Adjudication method for the test set
- Not Applicable. This concept is for resolving discrepancies among expert readers, which is not relevant for this IVD device's validation.
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
- No. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of IVD.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device (quantex Ferritin) is a standalone diagnostic test performed on a Clinical Chemistry System. Its performance is reported for the assay itself, without human interpretation as the primary output. However, it's not an "algorithm" in the AI sense.
7. The type of ground truth used
- Comparative Measurement: The "ground truth" for the method comparison study was the results obtained from the predicate device, AxSYM Ferritin.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set.
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).