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The Randox Liquid Immunoassay Premium Controls Level 1, Level 2, Level 3 and Tri level are liquid controls developed for use in the quality control of the quantitative assays stated on the package insert. This in vitro diagnostic device is intended for prescription use only.

Randox Liquid Immunoassay Premium Controls are manufactured at three levels. Level 1. Level 2 and Level 3. as well as a Tri Level product. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.

This document, K112337, describes the Randox Liquid Immunoassay Premium Controls. This is a quality control material and as such, the acceptance criteria and study proving it meets these criteria are focused on its stability and its equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "To assess the shelf life stability claims, real time stability studies of the device have been carried out. A shelf life stability claim of 12 months has been noted for the device, with 2 lots having achieved at least this claim, and tests ongoing to obtain real time data for 24 months."

• Sample Size for Test Set: 2 lots were used to achieve the 12-month stability claim.
• Data Provenance: The studies were "real time stability studies" conducted by Randox Laboratories Limited, based in the United Kingdom. This indicates the data is prospective and originates from the United Kingdom.

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

The document mentions: "The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories."

• Number of Experts: A "panel of experts" is mentioned, implying more than one, but a specific number is not provided.
• Qualifications of Experts: The document states their role was to ensure "clinically relevant" concentrations for "routine hospital laboratories." While their specific qualifications (e.g., radiologist with 10 years of experience) are not listed, their expertise is in clinical relevance for laboratory settings, likely implying clinical chemists, pathologists, or similar professionals with experience in laboratory medicine.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for the "panel of experts" that reviewed the analyte concentrations. It simply says they "reviewed" them. For the stability studies and the substantial equivalence claim, the "adjudication" is based on meeting the predefined stability parameters and demonstrating comparable performance to the predicate, likely through quantitative comparisons rather than expert consensus on individual "cases."

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

• No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not an AI-powered diagnostic tool. The concept of "human readers improving with AI" is not applicable here.

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

• Not applicable. This is a quality control material, not an algorithm. Performance is assessed on its inherent stability and accuracy in providing expected values for various analytes, which is its standalone function.

7. The Type of Ground Truth Used

• For Analyte Concentrations: The ground truth for the target analyte concentrations in the control materials was established through a "panel of experts" who determined clinically relevant levels. This aligns with expert consensus regarding appropriate control ranges.
• For Stability: The ground truth for stability is the ability of the control material to maintain its expected values over time under specified storage conditions. This is assessed through direct measurement and comparison to initial values or recognized standards over time.
• For Substantial Equivalence: The ground truth for proving substantial equivalence to the predicate device is a direct comparison of performance characteristics (e.g., analyte values, stability profile) to the established performance of the legally marketed predicate device (Bio-Rad Liquichek Immunoassay Plus Controls).

8. The Sample Size for the Training Set

• Not applicable. This device is a quality control material, not a machine learning model, so there is no "training set" in the conventional sense. The "training" or development of the product would involve formulating the controls to achieve desired analyte concentrations and stability, which isn't described in terms of a data set size like an algorithm.

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

• Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The development process focused on achieving specific, clinically relevant analyte concentrations and ensuring their stability.

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