(66 days)
OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.
OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.
Here's a breakdown of the acceptance criteria and the study details for the Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Intra-assay %CV | (Not explicitly stated, but typically 0.95), slope close to 1, intercept close to 0 when compared to a legally marketed predicate device. | Correlation coefficient: 0.98 |
| Slope: 0.92 | ||
| Y-intercept: 11.95 |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. Instead, it reports the performance characteristics, implying that these values met internal or regulatory expectations for substantial equivalence to the predicate device (Abbott IMX Ferritin).
2. Sample Size and Data Provenance for the Test Set:
- Sample Size for Test Set:
- Precision (Intra-assay): 3 levels of control material, 20 replicates each.
- Precision (Inter-assay): 3 levels of control material, duplicate assays over 5 days (total 20 replicates).
- Accuracy by Recovery: Not explicitly stated, but “different levels of ferritin” in pooled human serum, assayed in triplicate.
- Accuracy by Correlation: 70 serum samples.
- Data Provenance: Not explicitly stated. Likely retrospective clinical samples or laboratory-prepared samples (e.g., spiked samples for recovery). The country of origin is not mentioned, but given the manufacturer's location (Westwood, MA, USA), it's highly probable the data is from the USA.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
- Not Applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker. The "ground truth" for such devices is typically established through reference methods, certified standards, or comparison to a legally marketed predicate device, rather than expert consensus on interpretation. The document describes comparison to a commercially available Ferritin assay (the Abbott IMX Ferritin) as the reference for accuracy.
4. Adjudication Method (Test Set):
- Not Applicable. As noted above, adjudication by experts for interpretation is not relevant for this type of quantitative IVD device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is an automated in vitro diagnostic (IVD) device. MRMC studies are typically for image-based diagnostic systems where human readers interpret results, and the AI's effect on their performance is being evaluated. This device provides a quantitative measurement, not an interpretation that human readers would perform.
6. Standalone (Algorithm Only) Performance:
- Yes. The reported performance characteristics (Precision, Accuracy by Recovery, Accuracy by Correlation) are all measures of the OPUS Ferritin assay's performance by itself or in direct comparison to another assay, without human intervention in the result determination. The device's output is a quantitative ferritin value.
7. Type of Ground Truth Used:
- (For Accuracy by Correlation): Results from a commercially available, legally marketed Ferritin assay (Abbott IMX Ferritin). This serves as the comparative "ground truth" for evaluating substantial equivalence.
- For Precision: Based on the inherent variability within the assay when measuring control materials.
- For Accuracy by Recovery: Based on the known amount of ferritin spiked into samples.
8. Sample Size for the Training Set:
- Not explicitly stated/Not Applicable in the traditional sense. For an immunoassay like this, the "training" isn't typically based on a large dataset in the way a machine learning algorithm is trained. Instead, the assay's development involves:
- Assay Optimization: Iterative laboratory experiments to determine optimal reagent concentrations, incubation times, etc. This doesn't involve a distinct "training set" of patient samples in the same way an AI model would.
- Calibrator Definition: The six-level calibrator system is established with known concentrations to define the assay's standard curve for quantitative measurement.
9. How Ground Truth for the Training Set Was Established:
- Not applicable in the traditional sense of a "training set" for an AI algorithm.
- The "ground truth" for the calibrators would be established by preparing solutions with precisely known concentrations of ferritin, using highly purified ferritin standards. These standards would be traceable to recognized reference materials if available.
- The overall functionality of the immunoassay system (reagents, instrument) is developed and optimized as described in point 8, through biochemical and analytical testing, rather than "ground truth" labels on a dataset.
§ 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).