(67 days)
The Elecsys Rubella IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
The Elecsys Rubella IgG CalCheck 5 is a lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Elecsys Rubella IgG CalCheck 5, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary only states that the device was "evaluated for value assignment and stability." It does not provide specific numerical acceptance criteria or the reported device performance against those criteria. This type of information is typically detailed in the full testing report, which is usually not included in the public-facing 510(k) summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Only stated that the device was "evaluated for value assignment and stability." No specific results or adherence to criteria are given. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an IVD control, ground truth is typically established by the manufacturer through rigorous characterization of the control material against a reference method or known value. The document states the analyte is "spiked into the matrix at the desired concentration levels," implying the manufacturer establishes the target values.
4. Adjudication Method for the Test Set
This information is not applicable and thus not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or complex data where there might be inter-reader variability. For an IVD control, the "ground truth" (i.e., the target value of the control) is established by the manufacturer and is not subject to expert adjudication in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and often seeks to quantify the improvement in human performance with AI assistance. The Elecsys Rubella IgG CalCheck 5 is an in-vitro diagnostic control material, not a diagnostic device involving human interpretation, so such a study would not be applicable.
6. Standalone Performance Study
Yes, a standalone performance evaluation was done. The document states, "The Elecsys Rubella IgG CalCheck 5 was evaluated for value assignment and stability." This indicates that the performance of the control material itself was assessed. This is inherently a standalone evaluation as it assesses the control's properties directly, independent of a human-in-the-loop.
7. Type of Ground Truth Used
The ground truth used for this device would be the assigned target values and expected performance characteristics (e.g., stability over time) established by the manufacturer. The description states the device "consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels." This "spiking" process allows the manufacturer to determine the nominal (ground truth) concentration of the analyte within the control.
8. Sample Size for the Training Set
This information is not applicable to this device. The Elecsys Rubella IgG CalCheck 5 is a control material, not an algorithm or AI model that requires a training set. Its development involves chemical and biological formulation, purification, and characterization.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to this device, as there is no "training set." The ground truth for the control material itself (i.e., the intended concentration of Rubella IgG antibodies) is established by the manufacturer through the controlled spiking process and subsequent analytical validation using reference methods and assays.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.