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Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

This product is prepared from human whole blood with added preservatives and stabilizers. The control is provided in liquid form for convenience.

Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert. Each laboratory should establish its own means and acceptable ranges based on their own test system and tolerance limits.

Here's a breakdown of the acceptance criteria and study information for the Liquichek Whole Blood Immunosuppressant Control, based on the provided document:

This document is a 510(k) submission for a quality control material, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, the "acceptance criteria" here relate to the stability and similar performance to a predicate device, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the stability studies or other performance tests. It refers to "replicate analyses," implying multiple measurements were taken for the stability studies.

The data provenance is internal to Bio-Rad Laboratories, as stated in Section 8.0: "All supporting data is retained on file at Bio-Rad Laboratories." No country of origin is specified for the data itself, but the manufacturer is based in Irvine, California, USA. The studies appear to be prospective in nature, as they are establishing new stability claims for a new device.

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

This type of information is generally not applicable to the evaluation of a quality control material. The "ground truth" for a quality control material is its known concentration of analytes, established through highly controlled laboratory methods. Experts in the traditional sense (e.g., radiologists interpreting images) are not involved in setting the "ground truth" for chemical controls.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used for studies involving subjective human interpretation, such as image reading. This is not relevant for the evaluation of a quality control material, where stability and analytical performance are measured objectively.

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 that involve human interpretation (e.g., medical imaging AI). The Liquichek Whole Blood Immunosuppressant Control is a quality control material for laboratory instruments.

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

This concept is also not applicable. This device is a control material, not an algorithm or a diagnostic test that produces results that require human interpretation or algorithmic processing. Its performance is evaluated by its chemical stability and its ability to deliver consistent results when run on an assay.

7. The Type of Ground Truth Used

The ground truth for this quality control material is its known concentration of analytes. This is established through the manufacturing process and confirmed by analytical testing using reference methods. For example, "Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert." This indicates that the expected values for the control are determined by the manufacturer through precise analytical measurements.

8. The Sample Size for the Training Set

This concept is not applicable. This product is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set."

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

As there is no "training set" for this type of device, this question is not applicable.

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