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

Device Description

This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Liquichek™ ANA Control Homogeneous Pattern, Positive, based on the provided document:

This document describes a medical device, specifically a quality control material for laboratory tests, rather than a diagnostic device that performs analysis or diagnosis. Therefore, many of the typical acceptance criteria and study elements for diagnostic devices (like sensitivity, specificity, reader studies, etc.) do not apply. This submission is focused on demonstrating the stability and intended use of the control and its substantial equivalence to an existing product.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (from the document's "Product claims")	Reported Device Performance
Open vial stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C.	Stability studies determined the analyte is stable for 60 days when stored tightly capped at 2 to 8°C.
Shelf life: Control stable for 2 years when stored unopened at 2 to 8°C.	The control is stable for 2 years when stored unopened at 2 to 8°C.

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

Sample Size: The document does not specify a numerical "sample size" for the stability studies in the way a diagnostic study would. Instead, it refers to "stability studies" performed on the product itself.
Data Provenance: The studies were performed by Bio-Rad Laboratories. The location is Irvine, California, USA. The studies are prospective as they are "real time studies" conducted to determine shelf life and open-vial stability.

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

This question is not applicable to this type of device. As a quality control material, its "ground truth" is its inherent stability over time under specified conditions, not an interpretation by experts. The performance is assessed against predefined stability metrics (e.g., maintaining its intended reactivity as a positive control). Validation would typically involve laboratory testing, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the context of stability testing for a quality control material. Performance is measured against predefined chemical or biological stability parameters.

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

Not applicable. This device is a quality control material, not an AI-powered diagnostic device or an assistive technology for human readers. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a biochemical control material, not an algorithm or an AI system.

7. The Type of Ground Truth Used

For the stability studies, the "ground truth" is the demonstrated functional stability of the control material over specified periods (60 days open, 2 years unopened) when stored under controlled conditions. This would be established through laboratory assays confirming the control continues to elicit a positive, homogeneous ANA pattern.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not a machine learning algorithm that requires a training set.

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

Not applicable. As stated above, there is no training set for this type of device.

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