(7 days)
The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Troponin T assay.
Elecsys CalCheck Troponin T calibration verification solutions comprise three levels - low, mid. and high - each with a defined Troponin T concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Troponin T is intended for use in periodic verification of the calibration of the Elecsys Troponin T assay.
The Boehringer Mannheim Elecsys CalCheck Troponin T is manufactured using bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
The provided text describes the 510(k) summary for the "Elecsys CalCheck Troponin T" device. This device is a calibration verification material, not a diagnostic device that measures patient samples. Therefore, the acceptance criteria and study details are focused on the performance of the calibration material itself (value assignment and stability), rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for devices that provide patient results.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Value Assignment | The Elecsys® CalCheck™ Troponin T was evaluated for value assignment. (No specific quantitative criteria or results are provided, only that it was evaluated.) |
| Stability | The Elecsys® CalCheck™ Troponin T was evaluated for stability. (No specific quantitative criteria or results are provided, only that it was evaluated.) |
Note on Acceptance Criteria: The document is a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device. It states that the device "was evaluated for value assignment and stability." However, it does not explicitly list quantitative acceptance criteria for these evaluations or the specific results obtained. This level of detail is often found in the full 510(k) submission, not typically in the publicly available summary. For a calibration verification material, typical acceptance criteria would involve:
- Value Assignment: The measured values for each level (low, mid, high) must fall within a predefined range of the assigned target values. This range is usually determined by precision goals and clinical requirements for the assay being calibrated.
- Stability: The assigned values must remain within predefined acceptable limits over a specified period (e.g., shelf-life, open-vial stability) under various storage conditions (e.g., refrigerated, room temperature). Changes within these limits are usually compared to initial assigned values.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic performance on patient data. For a calibration verification material, the "test set" would refer to the lots or units of the Elecsys CalCheck Troponin T that were manufactured and evaluated.
- Sample size: Not specified. The summary states that the material "was evaluated for value assignment and stability," implying that a sufficient number of product lots or units were tested, but no concrete numbers are given.
- Data Provenance: Not applicable in the traditional sense of patient data. The evaluations would have been conducted internally by Boehringer Mannheim Corporation, likely in their manufacturing and R&D facilities. The country of origin for the data is therefore the USA, where Boehringer Mannheim Corporation is listed. The study would be prospective in the sense of manufacturing and testing new lots of the CalCheck material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable for a calibration verification material. "Ground truth" for this type of device relates to the accurately assigned concentrations of Troponin T within the calibration solutions.
- Establishing Ground Truth: The "ground truth" (i.e., the target concentration values for each level – low, mid, high) would be established through highly controlled analytical methods and reference materials, often involving a hierarchical traceability chain to international standards. This process typically involves:
- Using reference measurement procedures (RMPs) or highly accurate, validated methods.
- Comparing against certified reference materials (CRMs).
- Multiple measurements by skilled analytical chemists or laboratory professionals.
- The document does not detail the specific number or qualifications of individuals involved in the value assignment process, as it is a standard laboratory procedure for reference material production.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of diagnostic images or data in clinical studies. For a calibration material, discrepancies in value assignment would be resolved through re-analysis, investigation of analytical errors, or use of a reference method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are used to evaluate the impact of a diagnostic device (especially imaging AI) on human reader performance. The Elecsys CalCheck Troponin T is a calibration material, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Yes, in a sense. The "performance characteristics" evaluated (value assignment and stability) represent the standalone performance of the calibration material itself, independent of human interpretation of a diagnostic result. The device's output (its assigned value) is assessed directly through analytical methods.
7. The Type of Ground Truth Used
The ground truth used for this calibration verification material would be assigned values derived from:
- Reference materials: Highly pure human recombinant Troponin T.
- Analytical methods: Precisely measured concentrations using validated laboratory techniques, traceable to higher-order reference measurement procedures or international standards where available.
- Formulation specifications: The material is manufactured by "appropriately spiking" the analyte to achieve specific concentrations.
It is not based on expert consensus, pathology, or outcomes data, as those relate to diagnostic findings in patients.
8. The Sample Size for the Training Set
Not applicable. The Elecsys CalCheck Troponin T is a chemical reagent product, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.