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510(k) Data Aggregation
(28 days)
The Elecsys CK-MB CalCheck 5 is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys CK-MB reagent on the indicated Elecsys and cobas e innunoassay analyzers.
The Elecsys CK-MB CalCheck 5 is a lyophilized product consisting of human creatine kinase MB isoenzyme (CK-MB) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's an analysis of the acceptance criteria and supporting study for the Elecsys CK-MB CalCheck 5, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | For each lot, CalChecks are run in duplicate on at least three Elecsys 2010 analyzers. The assigned value is the median of at least 6 determinations. The assigned range is ±27% of assigned value for level 2 and ±30% for levels 3-5. For additional analyzers (MODULAR ANALYTICS E170), the median value must be within 10% of the master platform assigned value (Elecsys 2010). | Value assignment testing was conducted and passed pre-defined acceptance criteria. The specified value assignment procedure was performed: duplicate runs on at least three Elecsys 2010 analyzers, with the median of at least 6 determinations defining the assigned value. The assigned range was calculated as ±27% for level 2 and ±30% for levels 3-5. The same value assignment procedure was performed on the MODULAR ANALYTICS E170, and the median value obtained was compared to the Elecsys 2010; the criterion of being within 10% was met. These results allowed the assigned values from the master platform to be deemed valid for the Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use. |
| Open-Vial Stability (after reconstitution) | Supports a claim of stability up to 4 hours at 20-25°C. | Testing was performed and the data support the package insert claim that reconstituted Elecsys CK-MB CalCheck 5 is stable up to 4 hours at 20-25°C. |
| Shelf-Life Stability (unopened) | Supports a claim of 36 months at 2-8°C. | Real-time testing done at 2-8°C supports a claim of 36 months. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Value Assignment: For each lot, "at least three Elecsys 2010 analyzers" were used, with "at least 6 determinations" (duplicate runs on each of the analyzers). The exact number of lots or individual samples (CalChecks) tested is not specified beyond "for each Elecsys CK-MB CalCheck 5 lot manufactured." For the MODULAR ANALYTICS E170, an unspecified number of "median value" determinations were made and compared.
- Stability (Open-Vial & Shelf-Life): Not explicitly stated. The text only mentions "real-time and open-vial stability tests were conducted."
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It describes laboratory testing procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a device like a CalCheck (calibration verification and assay range verification control). The "ground truth" for a CalCheck is its assigned value, which is determined through a standardized, quantitative laboratory procedure on specified analyzers, not by expert consensus or interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is established through quantitative measurements and defined calculation methods (e.g., median of determinations), not through expert adjudication of qualitative findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a diagnostic control, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the CalCheck device itself when run on the specified Elecsys and cobas e immunoassay analyzers. All performance evaluations described (value assignment, stability) are essentially "standalone" in this context, demonstrating the intrinsic performance of the CalCheck material when processed by the intended instrumentation. There is no "human-in-the-loop" interpretation component for the CalCheck itself, beyond standard laboratory quality control practices.
7. The Type of Ground Truth Used
The ground truth used for this device is based on quantitative, assigned values determined through a standardized laboratory procedure involving multiple measurements on calibrated laboratory instruments (Elecsys 2010, MODULAR ANALYTICS E170, etc.). These assigned values are then used as a reference for calibration verification and assay range verification. It is not based on expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a physical diagnostic control, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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