(90 days)
The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
The IMMAGE Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples.
Here's a breakdown of the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Method Comparison (vs. Behring N Latex RF Reagent) | The document states "Equivalence is demonstrated through method comparison..." but does not provide specific quantitative acceptance criteria (e.g., correlation coefficient, bias limits) or the actual calculated values for these metrics. The provided table in Section 8.0 is largely illegible. |
| Stability (Shelf-life) | 24 months shelf-life |
| Stability (Open Container) | 14 day open container stability |
| Stability (Calibration) | 14 day calibration stability |
| Within-Run Imprecision (Level 1) | Mean: 124 IU/mL, SD: 2.5 IU/mL, %CV: 2.1 |
| Within-Run Imprecision (Level 2) | Mean: 299 IU/mL, SD: 4.5 IU/mL, %CV: 1.5 |
| Within-Run Imprecision (Level 3) | Mean: 637 IU/mL, SD: 12.4 IU/mL, %CV: 1.9 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison: The document does not explicitly state the number of samples used for the method comparison study. The table in Section 8.0 appears to contain data but is unreadable.
- Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is an in vitro diagnostic (IVD) reagent for quantitative determination of rheumatoid factor in serum/plasma. Its performance is evaluated against a predicate device and established analytical metrics (stability, imprecision), not by human expert interpretation of results. Therefore, there's no "ground truth" established by experts in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
This is not applicable for an IVD reagent performance study. Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., imaging studies) where there might be disagreement in ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is an IVD reagent and not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a chemical reagent, not an algorithm. Its performance is inherently standalone in that it produces a quantitative result without human interpretive input. The study focuses on the analytical performance of the reagent on the IMMAGE Immunochemistry System.
7. The Type of Ground Truth Used
- For Method Comparison: The "ground truth" is effectively the results obtained using the Behring N Latex RF Reagent (predicate device). The study aimed to demonstrate substantial equivalence by correlating results from the new device with the predicate.
- For Stability and Imprecision: The "ground truth" (or reference) is based on established analytical standards and measurements, ensuring the device yields accurate and reproducible results over time and within a run.
8. The Sample Size for the Training Set
This is not applicable. As a chemical reagent, there is no "training set" in the machine learning sense. The reagent's formulation and associated system parameters are developed through chemical and engineering processes, not through machine learning training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).