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

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

Here's a breakdown of the acceptance criteria and study information for the Bio-Rad Liquichek Diabetes Control, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device (K052838) with respect to stability and intended use, while noting differences in fill volume and the number of analytes.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • The document mentions "real-time stability studies" and "accelerated stability studies" were conducted.
   • No specific sample sizes (e.g., number of vials, number of replicates, number of lots) for these studies are provided in the summary.
   • The data provenance is internal to Bio-Rad Laboratories, with tests performed by "the manufacturer and/or independent laboratories." No specific country of origin for the data is mentioned, but Bio-Rad Laboratories is based in Irvine, California, USA.
   • The studies were prospective, as they were conducted to "establish" stability claims.

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

   • This information is not provided in the document. The studies conducted were stability studies for a quality control material, which typically involve laboratory testing and comparison to established methods or specifications, rather than expert interpretation of results. The "ground truth" for a control material like this would be its measured analyte concentration and its stability characteristics under various conditions.

3. Adjudication Method for the Test Set:

   • This is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth from subjective data (e.g., imaging studies). For stability testing of a quality control material, the measurements are objective.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where AI assists human readers. The Liquichek Diabetes Control is a quality control material, not a diagnostic device that humans interpret.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, a standalone study in the context of an algorithm's performance was not done. This device is a physical quality control material for laboratory instruments, not an algorithm. The "performance" here refers to its stability and ability to maintain consistent values.

6. Type of Ground Truth Used:

   • The ground truth for the stability studies would be analytical measurements of the Hemoglobin A1C analyte over time under various storage conditions. These measurements are compared against pre-defined specifications or the initially assigned values to determine stability. The "Value Assignment" section states that mean values and ±3SD ranges were derived from testing on the specific lot of product by the manufacturer and independent laboratories.

7. Sample Size for the Training Set:

   • This concept is not applicable to this device. As a quality control material, there is no "training set" in the machine learning sense. The "value assignment" process involves testing the manufactured product to establish its initial characteristics.

8. How the Ground Truth for the Training Set Was Established:

   • This is not applicable. The "ground truth" for the control material's value is established through analytical testing of the actual product lot. The document states: "The mean values and the corresponding ±3SD ranges printed in this insert were derived... The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a bio-reductive method... It is recommended that each laboratory establish its own acceptable ranges and use those recommended in this insert only as guides." This indicates a combination of manufacturer testing and a recommendation for end-users to verify.

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