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The Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

These products are prepared from human serum with added preservatives. These controls are provided in liquid form for convenience

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting the limitations in the given information for some of your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the stability studies or any "test set" in the context of diagnostic accuracy. The study is described as "Stability studies," which are typically laboratory-based assessments of product degradation over time. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

This information is not provided in the document. The "ground truth" here would be the actual stability of the control analytes over time. This is typically determined by analytical methods, not expert consensus in the same way clinical diagnostic accuracy is.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies involving human interpretation. Here, the "study" is a stability assessment.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human readers in diagnostic tasks, which is not the purpose of this device (a quality control set).

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

No, a standalone performance study was not done. This device is a quality control material, not an algorithm. Its performance is related to its stability and ability to elicit the expected immunofluorescent patterns, not an independent algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the stability studies would be the analytical measurements of the concentration or reactivity of the ANA patterns in the controls over time. This is determined through established laboratory methods, comparing the results over the noted timeframes to initial values or reference standards. The document states "All supporting data is retained on file at Bio-Rad Laboratories," implying internal analytical testing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a manufactured control material, not an AI algorithm requiring a "training set."

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

This information is not applicable/not provided as there is no "training set" for this type of device.

Overall Study Summary:

The device, Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, underwent stability studies to determine its shelf life and open-vial stability. These studies supported the claims that:

• Once opened, the analytes in the controls are stable for 60 days when stored tightly capped at 2 to 8°C.
• The control is stable for 2 years when stored unopened at 2-8°C.

The document indicates these are "Product claims" based on the performed stability studies, with "All supporting data... retained on file at Bio-Rad Laboratories." The specifics of the methodology, including the number of batches tested, the frequency of testing, and the exact analytical methods used to verify stability, are not detailed in this summary. The purpose of this submission (K024230) was to demonstrate substantial equivalence to previously cleared predicate devices for the intended use as an unassayed quality control set for indirect immunofluorescent testing of antinuclear antibodies.

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