Search Results

Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA autoantibodies.

Liquichek Anti-dsDNS Control 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 preservative.

This looks like a 510(k) submission for an in vitro diagnostic device, specifically a quality control product. The information provided heavily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device's own performance against acceptance criteria in the way a clinical diagnostic or AI-powered device would.

Therefore, many of the requested categories (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable in the context of this specific regulatory document. The "device performance" in this context refers to its characteristics compared to the predicate, not clinical accuracy or efficacy.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the typical sense of performance metrics for an AI or clinical diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to an existing legally marketed device (the predicate). The "performance" reported is a comparison of technological characteristics.

Note: While Form, Levels, Analytes, and Open Vial Claim show differences, the overall argument for substantial equivalence is made, likely by emphasizing the core "monitoring immunoassay procedures for dsDNA/nDNA autoantibodies" with a human serum matrix and similar storage conditions. The specific differences are acknowledged but not deemed to preclude equivalence for its intended use as a control.

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

• Sample Size: Not applicable. This is not a study testing the diagnostic accuracy or performance on patient samples. It's a characterization of a quality control product.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This type of study is for evaluating the impact of a diagnostic aid (like AI) on human reader performance, which is not relevant for a quality control product.
• Effect Size: Not applicable.

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

• Standalone Study: No. This device is a quality control material, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of diagnostic accuracy. For a quality control material, the "ground truth" would be the assayed values of the analytes within the control, which are then used to monitor other assays. However, this document describes it as an "unassayed quality control," meaning its exact values are not provided by the manufacturer but determined by the user's specific assay. The primary "ground truth" for this 510(k) is the established characteristics of the predicate device.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. There is no training set for a quality control product.

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

• Ground Truth Establishment: Not applicable.

Ask a specific question about this device