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The Elecsys CA 19-9 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 CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of human CA 19-9 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

This document describes the Elecsys CA 19-9 CalCheck 5, an assayed control for use in calibration verification and assay range verification for the Elecsys CA 19-9 reagent on Elecsys and cobas e immunoassay analyzers.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner for the performance study. Instead, it states that the device "was evaluated for value assignment and stability." The reported performance is the established "Check Target Values" for each of the five levels of the CalCheck. These values essentially act as the performance targets that the control material is designed to demonstrate when used with the Elecsys CA 19-9 reagent.

Since specific performance metrics like accuracy, precision, or recovery rates against acceptance limits are not provided in the summary, the table below reflects what is available.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample size used for the performance evaluation of value assignment and stability. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) summary for an in vitro diagnostic control, it's highly likely to be prospective testing performed by the manufacturer, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. For a control material like this, the "ground truth" (i.e., the target values) would typically be established through highly precise and accurate measurement methods by the manufacturer during the production and analytical characterization of the control lots, rather than by external experts in the same way, for instance, a diagnostic imaging AI might use clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The development of target values for a quality control material involves robust analytical methods and statistical analysis by the manufacturer, not a consensus or adjudication process involving multiple external experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved (e.g., radiology AI). The Elecsys CA 19-9 CalCheck 5 is an in vitro diagnostic control material, and its performance is assessed analytically, not through human reader interpretation.

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

This question is not directly applicable in the terms usually associated with AI or imaging devices. The Elecsys CA 19-9 CalCheck 5 itself is a physical control material, not an algorithm. Its performance is assessed as a standalone product (i.e., its ability to yield expected results when measured by the Elecsys CA 19-9 assay) in laboratory settings. The document states it was "evaluated for value assignment and stability," which implies such standalone analytical performance testing was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the Elecsys CA 19-9 CalCheck 5 is the assigned target values for each of its five levels, along with its established stability characteristics. These values are determined by the manufacturer (Roche Diagnostics) through their internal analytical methods and quality control processes during the development and manufacturing of the control material. It is a form of analytical reference standard determination.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical control material, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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The Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

The provided document describes the Elecsys® CA 19-9 CalCheck™ and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information requested in your prompt. This document is a 510(k) summary submitted to the FDA, which typically focuses on demonstrating substantial equivalence to a legally marketed device rather than detailing extensive performance studies with specific statistical acceptance criteria and ground truth establishment methods.

The "Performance Characteristics" section simply states: "The Elecsys® CA 19-9 CalCheck™ was evaluated for value assignment and stability." This is a very high-level statement and lacks the specifics you are looking for.

Therefore, for your request, I can only provide the information that is present in the document.

Missing Information:

The document does not provide the following details:

• A table of acceptance criteria and reported device performance (beyond the general statement that it was "evaluated").
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
• Specific details of a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

Information Available from the Document:

Here's what can be extracted from the provided text, related to the device and its intended use:

• Device: Elecsys® CA 19-9 CalCheck™
• Intended Use: For use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
• Performance Evaluation: The device "was evaluated for value assignment and stability."

Because the requested granular details regarding acceptance criteria, study design, ground truth, and sample sizes for performance evaluations are not present in the provided 510(k) summary, I cannot fill in the table or answer most of your specific questions. Regulatory submissions for diagnostic controls often focus on demonstrating that the control material performs as expected in terms of its assigned values and stability, rather than extensive clinical efficacy or reader studies like those for AI-powered diagnostic devices.

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