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510(k) Data Aggregation
(150 days)
The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases associated with iron metabolism 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.
The Vitalab Iron Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantitative determination of total iron in serum and plasma. Iron in the sample is specifically released from transferrin using an acidic buffer. The released iron is then reduced and reacts with a chromogenic indicator. The increase in absorbance at 578 nm is measured photometrically. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.
The provided text describes the acceptance criteria and study for the Vitalab Iron Reagent Kit and Vitalab Selectra Analyzer, which are used as a system for the quantitative determination of total iron in serum and plasma.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Good linear relationship (regression statistics) | (Vitalab Recoveries) = 0 ug/dL + 1.017 x (Concentration), n = 44 |
| Precision (Within Run) - Serum 1 (57 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 0.9, %CV = 1.6% |
| Precision (Within Run) - Serum 2 (158 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 0.9, %CV = 0.6% |
| Precision (Within Run) - Serum 3 (260 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 1.0, %CV = 0.4% |
| Precision (Total) - Serum 1 (57 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 1.5, %CV = 2.7% |
| Precision (Total) - Serum 2 (158 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 3.0, %CV = 1.9% |
| Precision (Total) - Serum 3 (260 ug/dL) | Not explicitly stated but typically low CV% | 1SD = 5.2, %CV = 2.0% |
| Method Comparison with Competitive Reagent | Good correlation and agreement | Selectra = 1.1 µg/dL + 0.988 x Competitive Reagent |
| Method Comparison (Deming Statistics) | Not explicitly stated but typically small bias/error | s(y.x) = 2.3 µg/dL |
| Detection Limit (Claimed) | Documented | 8.2 µg/dL iron (based on observed standard deviation of 2.8 µg/dL) |
| Onboard Reagent Stability | Less than 2% coefficient of variation (CV%) after 14 days | All cases: statistical estimates of CV < 2% |
| Calibration Stability | Less than 2% coefficient of variation (CV%) after 7 days | All cases: statistical estimates of CV < 2% |
2. Sample Size Used for the Test Set and the Data Provenance
- Linearity: n = 44 (This likely refers to the number of data points used for the regression analysis). The text does not specify the provenance (country of origin) or if it was retrospective or prospective.
- Precision:
- Serum 1: n = 66
- Serum 2: n = 66
- Serum 3: n = 66
- The text does not specify the provenance (country of origin) or if it was retrospective or prospective for these control serum samples. It states "commercially available control serum," implying a standardized, perhaps manufactured, source.
- Method Comparison: "Mixed serum and plasma specimens collected from adult patients." The sample size is not explicitly provided for the method comparison, only a range of values (9 - 287 µg/dL) was observed. The text does not specify the provenance (country of origin) or if it was retrospective or prospective.
- Detection Limit: Repetitive assay of a "diluted serum pool." The exact number of repetitions is not given, but it implies multiple measurements.
- Stability Studies: "Assay of serum after the claimed periods." The number of samples/replicates is not specified, but it was sufficient to generate statistical estimates of coefficient of variation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as this device is an in-vitro diagnostic (IVD) for quantitative iron measurement, not an imaging or interpretive device that typically requires expert review for ground truth establishment. The "ground truth" for the performance metrics is based on established analytical chemistry principles, reference methods, and statistical analysis using control materials or comparative measurements.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for diagnostic interpretations (e.g., in radiology studies) where human disagreement needs resolution.
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
This information is not applicable. This is an IVD device for laboratory measurement, not an AI-assisted diagnostic tool that would involve human readers or interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an "algorithm only" device as traditionally understood for AI/CAD systems. This device is a reagent kit and analyzer system for a chemical assay. Its performance is inherently "standalone" in the sense that the measurement results are generated by the instrument and reagents, independent of human interpretation for the measurement itself. The accuracy of these measurements is assessed against reference standards or comparative methods.
7. The type of ground truth used
- Linearity, Precision, Detection Limit: Ground truth is established based on known concentrations in control materials, standards, or spiked samples, and statistical measures derived from replicate assays.
- Method Comparison: Ground truth is established by comparison to a "Competitive Reagent", assumed to be a clinically accepted or predicate method.
8. The sample size for the training set
This information is not explicitly provided and is likely not applicable in the same way it would be for a machine learning model. For this type of chemical assay, "training" typically refers to the calibration process. The device uses an "iron calibrator" and its "calibration stability claims are documented." The text refers to a "Vitalab Iron Reagent Kit, which contains an iron calibrator," and states it "is equivalent to the Beakman Iron Reagent Kit, calibrated with Vitalab Iron Reagent Kit". This suggests the calibrator itself serves the function of establishing the measurement curve.
9. How the ground truth for the training set was established
As inferred from point 8, the "training" (calibration) ground truth is established by the iron calibrator included in the kit. Calibrators are typically manufactured with precisely known concentrations, often traceable to international reference materials or established methods. The equivalence to the Beckman Coulter, Inc. kit also suggests a benchmarking against an established standard.
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