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Liquichek ANA Control, Centromere Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Liquichek ANA Controllee preservatives and stablizers. This product is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a provided in liqu

This device, the Bio-Rad Liquichek ANA Control, Centromere Pattern, is a quality control product for laboratory testing, not an AI/ML powered medical device. Therefore, the standard information regarding acceptance criteria and studies proving the device meets them, in the typical sense of AI/ML performance metrics, is not directly applicable.

However, I can extract information related to its intended use, comparative characteristics to a predicate device, and the regulatory process which implies its "acceptance" for market.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a control product, its "performance" is primarily defined by its characteristics and its ability to serve its intended purpose in monitoring indirect immunofluorescent testing. The provided document details a comparison to a predicate device, showing the similarities in key attributes which serve as the basis for its substantial equivalence.

"Acceptance Criteria" for this type of device would generally revolve around:

• Manufacturing Quality: Ensuring the product is manufactured consistently and meets defined specifications (e.g., concentration of ANA, stability, sterility).
• Stability: Maintaining its stated characteristics over its shelf life and open-vial period.
• Suitability for Intended Use: Demonstrating that it correctly functions as a control in ANA indirect immunofluorescent assays.
• Substantial Equivalence: Proving to the FDA that it is as safe and effective as a legally marketed predicate device.

The provided document details the basis for its substantial equivalence to the Kallestad Quantafluor Autoantibody Positive Control, highlighting shared matrix (human serum) and storage conditions, and a similar intended use as a control for ANA testing (though the new device is specific to Centromere Pattern). The differences (liquid form, specific ANA pattern, multiple levels, different open vial claim) would have been assessed by the FDA to ensure they don't raise new questions of safety or effectiveness.

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

This information is not applicable in the context of this 510(k) submission. The device is a quality control material, not a diagnostic test with a "test set" of patient data in the AI/ML sense. The "testing" for such a device would typically involve internal validation by the manufacturer to demonstrate its stability and manufacturing consistency, and then its performance as a control within specific lab assays. No details on such internal testing are provided in this summary.

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

This information is not applicable. There is no "ground truth" establishment in the context of patient data for this quality control product. Its "truth" is its inherent composition and stability as a control material.

4. Adjudication Method:

This information is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. This is not an AI-powered diagnostic device, and therefore, no MRMC studies comparing human readers with and without AI assistance would be performed.

6. Standalone Performance:

This information is not applicable in the AI/ML sense. "Standalone performance" for this device would refer to its intrinsic characteristics (e.g., concentration of antibodies, stability) which are verified during manufacturing and quality control. The 510(k) primarily focuses on demonstrating substantial equivalence, not a standalone performance study report.

7. Type of Ground Truth Used:

For a quality control material, the "ground truth" is intrinsically defined by its manufacturing specifications and the characterization of the human serum used. The manufacturer would establish the expected range for the Centromere ANA pattern in their control lots. This isn't pathology, outcomes data, or expert consensus in the same way it would be for a clinical diagnostic test for patient samples. Instead, it's about the composition and stability of the control product itself.

8. Sample Size for the Training Set:

This information is not applicable as this is not an AI/ML device requiring a training set.

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

This information is not applicable.

Summary of Regulatory Acceptance for K984397:

The FDA determined that the Bio-Rad Liquichek ANA Control, Centromere Pattern, was substantially equivalent to the predicate device (Kallestad Quantafluor Autoantibody Positive Control). This determination indicates that the FDA reviewed the information provided by Bio-Rad (including the comparison table above) and concluded that the new device is as safe and effective as the legally marketed predicate device for its stated intended use. This regulatory decision serves as the "acceptance" that the device meets the necessary criteria for market entry.

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