(50 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia.
A particle enhanced immunoturbidimetric assay in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 552 nm.
Here's a summary of the acceptance criteria and study information for the Ferritin Generation 2 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the performance of the Ferritin Generation 2 is demonstrated by direct comparison to a predicate device (COBAS Integra Ferritin assay, K963292). The assumption is that matching or improving upon the predicate's performance indicates substantial equivalence and meets acceptance.
| Feature | Implicit Acceptance Criteria (Relative to Predicate) | Ferritin Generation 2 Performance | Predicate Device Performance (COBAS Integra Ferritin) |
|---|---|---|---|
| Precision | Similar or improved CVs | Within run CV: | |
| 9.0% @ 19.8 ng/ml | |||
| 2.5% @ 107.5 ng/ml | |||
| Between Day CV: | |||
| 7.8% @ 20.3 ng/ml | |||
| 3.4% @ 157.0 ng/ml | Within run CV: | ||
| 9.9% @ 19 ng/ml | |||
| 1.2% @ 260 ng/ml | |||
| Between Day CV: | |||
| 10.2% @ 19 ng/ml | |||
| 3.8% @ 260 ng/ml | |||
| Method Comparison | Strong correlation (r-value close to 1) and linear agreement with predicate | Bablok/Passing: | |
| $y = 1.30x + 12.98$ ng/ml | |||
| $r = 0.922$ | Bablok/Passing: | ||
| $y = 0.84x + 0.8$ ng/ml | |||
| $r = 0.992$ (vs. commercially available system) | |||
| Limitations | No significant interference / similar limitations | Icterus: No significant interference | |
| Hemolysis: No significant interference up to 596 µmol/l | |||
| Lipemia: No significant interference up to 160 mg/dL | |||
| Rheumatoid factors: No significant interference | Icterus: No significant interference | ||
| Hemolysis: No significant interference | |||
| Lipemia: No significant interference | |||
| Rheumatoid factors: No significant interference | |||
| Prozone Effect | Similar or improved high-end detection | No effect up to 10,000 ng/ml | Integra 400/400 plus: No effect up to 4300 ng/ml |
| Integra 700/800: No effect up to 45,000 ng/ml | |||
| Analytical Sensitivity (LDL) | Similar or improved lower detection limit | 7.5 ng/ml | 5 ng/ml |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the performance studies. It only presents the results of these studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided text. The studies relate to the performance of an in vitro diagnostic reagent system (a lab test), not an imaging-based or clinical diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not available in the provided text. Adjudication methods are typically relevant for studies involving human interpretation of results, which is not the primary focus of this device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
An MRMC comparative effectiveness study was not done. This type of study is not applicable to an in-vitro diagnostic reagent system like Ferritin Generation 2, which produces quantitative numerical results rather than interpretations requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the diagnostic reagent system itself. The precision, method comparison, and interference studies assess the device's analytical performance independent of human interpretation beyond standard laboratory procedures (e.g., pipetting, running the instrument).
7. The Type of Ground Truth Used
For the Method Comparison study, the "ground truth" for the Ferritin Generation 2 device was a predicate device, specifically the COBAS Integra Ferritin assay. The comparison assessed how closely the new device's measurements correlated with the established predicate.
For other analytical performance characteristics (Precision, Limitations, Prozone Effect, Analytical Sensitivity), the "ground truth" implicitly refers to the true analytical values of the samples being tested, typically derived from reference materials or highly accurate reference methods, although these are not explicitly detailed. The device is designed to quantitatively determine human ferritin, and the ground truth would be the actual ferritin concentration in the samples.
8. The Sample Size for the Training Set
This information is not available in the provided text. This device is a reagent system, not an AI/ML-based algorithm that typically has a "training set" in the conventional sense. Its development would involve analytical testing and validation rather than a data training process.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is not an AI/ML system with a "training set." The performance characteristics are established through various analytical validation studies using reference materials and patient samples.
§ 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).