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The use of control material to estimate test precision in a test system and to detect systematic deviation that may arise from reagent or analytical instrument variation in the measurement of cyclosporine A, tacrolimus and rapamycin.

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This document is a 510(k) clearance letter from the FDA for a quality control material called "Rap/Tac/CsA Control." It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is a control material for estimating test precision and detecting systematic deviation in a test system, not a diagnostic device itself.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls. The "Indications for Use" section further clarifies its purpose as a quality control material.

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The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

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I am sorry, but the provided text from the FDA letter [K982845](https://510k.innolitics.com/search/K982845) only contains information about the regulatory approval of a device called "Cardiac Markers Control (Single Use) Levels 1,2,3". It states that the device is substantially equivalent to previously marketed devices and is for quality control purposes, specifically "to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation."

However, the document does not contain any information regarding acceptance criteria, device performance data from a study, sample sizes (for test or training sets), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

Therefore, I cannot provide an answer to your request based on the given input.

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The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviation that may arise from reagent or analytical instrument in the measurement of cyclosporin A and tacrolimus.

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This document is a 510(k) premarket notification letter from the FDA regarding an 'Immunosuppressant (Whole Blood) Control' device, it does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter confirms that the device is "substantially equivalent" to previously marketed devices and permits it to be marketed. However, it does not include:

1. A table of acceptance criteria and reported device performance: This information would typically be found in the applicant's submission, not in the FDA's decision letter.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and their qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. MRMC comparative effectiveness study details: Not applicable as this is a control material, not an AI-assisted diagnostic device for human readers.
6. Standalone algorithm performance: Not applicable.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable (this is not an AI algorithm requiring a training set).
9. How ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory approval based on substantial equivalence, and indicates the "Indications For Use" as: "The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviation that may arise from reagent or analytical instrument for quantification of cyclosporin A and tacrolimus."

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The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

CARDIAC MARKERS CONTROL (THREE LEVELS)

I am sorry, but the provided text is a 510(k) clearance letter for "Cardiac Markers Control Levels 1, 2, and 3". This letter acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.

The letter focuses on regulatory approval and mentions "control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations," which refers to the purpose of the control material, not a study evaluating the control material itself.

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Ask a specific question about this device