(162 days)
The Elecsys CYFRA 21-1 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 CYFRA 21-1 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys CYFRA 21-1 CalCheck 5 is a lyophilized product consisting of cytokeratin in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
CYFRA 21-1 CalCheck 5 is a lyophilized human serum matrix with added cytokeratin in five concentration ranges. The CalCheck includes:
- o CYFRA 21-1 CalCheck 1: approximately
This document describes the premarket notification (510(k)) for the Elecsys CYFRA 21-1 CalCheck 5, a control device used for calibration verification and assay range verification for the Elecsys CYFRA 21-1 reagent on specific immunoassay analyzers.
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1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Value Assignment: Assigned value for each CalCheck level on cobas e 601/MODULAR ANALYTICS E170 analyzers defined as the mean value obtained over at least six determinations (duplicate runs on at least three analyzers). | Value assignment testing was conducted and passed pre-defined acceptance criteria. The assigned values are published. |
| Assigned Range: For levels 2-5, the assigned range is calculated as ±21% of the assigned value. | The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use. |
| Cross-Platform Comparability (cobas e 411 vs. cobas e 601): Mean value obtained on the additional analyzer (cobas e 411) must be within 10% of the master platform (cobas e 601) assigned value. | This acceptance criterion was met, deeming assigned values from the master platform valid for Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers. |
| Accelerated Stability (3 weeks at 35°C): Recovery of the stressed material compared to freshly reconstituted material was calculated. (Specific numerical acceptance criteria for recovery are not provided in the document, only that the study was conducted and recovery was calculated). | The study was conducted. No specific numerical performance values for recovery are explicitly stated as "met" or "non-met" in this summary section, only that the study was performed. |
| On-board Stability (6 hours at 20-25°C): Test material compared as a % to freshly reconstituted reference. (Specific numerical acceptance criteria for % comparison are not provided). | The study was conducted. No specific numerical performance values for % comparison are explicitly stated. |
| Real-Time Stability (Transferred from CalSet material): Stored CalSet reagents tested at T=0 and specified intervals over shelf life + one month. (Implies performance within expected ranges, but specific criteria are not listed). | The study was conducted, and the results are transferable to the CalCheck material to support a 12-month shelf life claim. |
2. Sample sizes used for the test set and the data provenance
- Value Assignment: For each Elecsys CYFRA 21-1 CalCheck 5 lot, each CalCheck level is run in duplicate on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers. This means at least 6 determinations per CalCheck level per lot. The document implies this data is generated internally by Roche Diagnostics, likely in laboratories in the USA (Indianapolis), Germany (Mannheim, Penzberg) based on the establishment registration. This is prospective data generation for product release and verification.
- Accelerated Stability: "One CYFRA 21-1 CalCheck 5 lot was evaluated on one cobas e 411 analyzer." Tests were performed in duplicate. This is likely prospective data.
- On-board Stability: "One CYFRA 21-1 CalCheck 5 lot was evaluated on one cobas e 411 analyzer." Samples tested in duplicate. This is likely prospective data.
- Real-Time Stability: Conducted on the CYFRA 21-1 CalSet material. "Stored CalSet reagents were tested at time point T=0 and at specified intervals over the shelf life of the device up to the planned shelf life plus one month." No specific sample size (number of lots or tests) is provided for the CalSet study. The data provenance is internal to Roche Diagnostics, prospective for shelf-life determination.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section describes a quality control material, not a diagnostic device that relies on interpretation of data by experts. The "ground truth" here is the assigned value of the analyte concentration in the control material. This is established through a quantitative measurement process on pre-defined analyzers rather than expert consensus on, for example, medical images or patient diagnoses. Therefore, the concept of "experts establishing ground truth" as typically applied to image-based AI or clinical decision support AI is not directly applicable. The "experts" in this context would be the skilled laboratory personnel who perform the assays according to established protocols and the statisticians/scientists who determine the assigned values based on the collected analytical data. No specific number or qualifications are mentioned for such roles.
4. Adjudication method for the test set
Not applicable for a quality control material where quantitative analytical results are compared against pre-defined ranges and values. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple readers provide independent interpretations.
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 quality control material used to verify the performance of an immunoassay analyzer and its reagents, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device in the sense that it is a physical control material. The performance of the device itself (its stability and assigned values) is evaluated, not an algorithm's classification capabilities. It is used with an immunoassay analyzer, but its own performance doesn't involve an "algorithm only" classification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is the analytically determined assigned value of the cytokeratin concentration within the control material. This is established through rigorous laboratory testing using calibrated instruments and methods, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is a physical control material, not a machine learning model that requires a training set. The reference to "master platform assigned value" and "additional analyzer" implies a validation step, but not a training process in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.