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The Elecsys Folate III 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 Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys Folate III CalCheck 5 is a lyophilized product consisting of Folate in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided 510(k) summary (K094053) describes a device called "Elecsys Folate III CalCheck 5," which is an assayed control for use in calibration verification and verification of the assay range for the Elecsys Folate III reagent on immunoassay analyzers. This type of device is a quality control material and as such, the submission does not involve clinical studies with human participants, expert ground truth, or multi-reader multi-case studies, which are typically associated with diagnostic or AI-powered medical devices. The acceptance criteria and performance data for this device relate to its analytical accuracy and precision in controlling an in vitro diagnostic assay.

Therefore, many of the requested categories are not applicable or cannot be extracted from this specific document, as they pertain to clinical efficacy studies rather than analytical performance of a control solution.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of explicit acceptance criteria or reported device performance in the format typically seen for a new diagnostic device. For an assayed control, acceptance criteria would typically involve demonstrating that the control material consistently yields expected values within a defined range when run on the target assay. The submission primarily focuses on establishing substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable directly in the context of a quality control material. The "test set" for an assayed control would typically involve rigorous analytical testing in a laboratory setting to confirm its assigned values and stability. The 510(k) summary does not detail the size or provenance of such analytical testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the sense of expert clinical diagnosis, is not relevant for an assayed control material. The "ground truth" for a control material is its assigned concentration, which is determined through a robust analytical process by the manufacturer, not by clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies among expert readers, which is not relevant for an assayed control.

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, not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an assayed control, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the clinical sense. For a quality control material, the "ground truth" is typically the assigned value of the analyte (Folate in this case) within the control, which is established by the manufacturer through precise analytical methods and verified against reference materials or methods. The 510(k) summary doesn't detail this process.

8. The sample size for the training set

Not applicable. This device is a quality 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 above, this is not an algorithm requiring a training set.

Summary of the K094053 Submission:

The K094053 submission for the Elecsys Folate III CalCheck 5 is for an assayed control used to verify the performance of an in vitro diagnostic assay (Elecsys Folate III reagent). As such, the focus of the submission is on demonstrating its analytical performance and substantial equivalence to a predicate device (Elecsys HCG+β CalCheck 5 (K092168)). The 510(k) summary describes the device as a lyophilized product consisting of Folate in a human serum matrix, with analyte spiked in at desired concentrations.

For devices of this nature, "acceptance criteria" and "study data" would typically refer to:

• Accuracy: The ability of the control to yield results within a specified range relative to its assigned value.
• Precision (Repeatability and Reproducibility): The consistency of results when the control is run multiple times, by different operators, or on different instruments.
• Stability: The ability of the control to maintain its assigned values over its shelf life and during storage.
• Matrix Equivalence: Ensuring the control matrix behaves similarly to patient samples in the assay.

These analytical performance characteristics would be demonstrated through internal validation studies by Roche Diagnostics. However, the provided 510(k) summary document itself does not include the detailed analytical study report, raw data, or a explicit table of acceptance criteria and results for the Elecsys Folate III CalCheck 5. Such details are typically found in the full 510(k) submission, but are not always part of the publicly available summary. The summary focuses on the administrative details, device description, and intended use to establish substantial equivalence.

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