(30 days)
The Elecsys Troponin I 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 Troponin I reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Troponin I CalCheck 5 is a lyophilized product consisting of recombinant human cardiac Troponin I in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This document describes the Elecsys Troponin I CalCheck 5, a lyophilized product containing recombinant human cardiac Troponin I in a human serum matrix. It is intended for use in calibration verification and to verify the assay range established by the Elecsys Troponin I reagent on Elecsys and cobas e immunoassay analyzers.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | "an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin I reagent" | Substantially equivalent to predicate device with the same intended use for Troponin I. |
| Levels | Five | Five |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum matrix | Human serum matrix |
| Handling Instructions | "Reconstitute the contents of each vial with exactly 1.0 mL distilled or deionized water; Allow the bottle to stand closed for 15 minutes. Mix gently by inversion to ensure homogeneity." | Same as predicate device. |
| Stability (Unopened) | Store at 2-8°C until expiration date | Same as predicate device. |
| Stability (Reconstituted) | 20 – 25°C : 4 hrs | Same as predicate device. |
| Value Assignment | Not explicitly stated, implied to be comparable to predicate. | Evaluated. Data indicate substantial equivalence. |
| Stability (general) | Not explicitly stated, implied to be comparable to predicate. | Evaluated. Data indicate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the conventional sense of a clinical study. The evaluation focused on "value assignment and stability" of the control material itself. Therefore, the "sample size" would refer to the number of vials/batches tested for these characteristics. This information is not provided in the summary.
Data Provenance: Not specified, but generally, studies for IVD control materials are conducted internally by the manufacturer, typically in a controlled laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a characteristic for a diagnostic device that interprets or classifies. For an assayed control material, "ground truth" relates to the assigned value and stability of the control and is established through rigorous internal testing and calibration processes, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable for a control material. Ground truth is established through laboratory measurement and metrological traceability, not expert adjudication of individual results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices) to assess reader performance with and without AI assistance. This document describes an assayed control material, which does not involve human readers interpreting results in the same way.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This concept is not directly applicable. The device is a "control" material, not an "algorithm." Its performance is inherent in its chemical and physical properties (concentration, stability). The "study" for this device evaluated its intrinsic characteristics (value assignment and stability) against its predicate, not its performance as a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For a control material like Elecsys Troponin I CalCheck 5, the "ground truth" would be:
- Assigned Values: The target concentrations of Troponin I in each of the five levels, established through a rigorous value assignment process, usually involving reference methods or highly characterized internal standards.
- Stability Specifications: The predefined parameters for how long the control material maintains its assigned values under specified storage and handling conditions.
The document states, "The Elecsys Troponin I CalCheck 5 was evaluated for value assignment and stability." This indicates these intrinsic properties formed the basis of the performance evaluation.
8. The Sample Size for the Training Set
Not applicable. This device is a control material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not a machine learning device, there is no training set or associated ground truth in that context.
§ 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.