(23 days)
The Liquichek™ ANA Control, Speckled Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
The provided document describes a medical device, the Liquichek™ ANA Control, Speckled Pattern, Positive, which is an unassayed quality control for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA). This is a control product for laboratory use, not an AI or imaging device, so many of the requested criteria (e.g., effect size of human readers with AI, adjudication methods, multi-reader multi-case studies, ground truth for training/test sets) are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this control device primarily relate to its stability.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open vial stability | Analyte stable for 60 days when stored tightly capped at 2-8°C. |
| Shelf life (unopened vial stability) | Stable for 2 years when stored unopened at 2-8°C. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI device. For this control material, stability studies were performed. The sample size for these studies is not explicitly stated. The data provenance would be from Bio-Rad Laboratories' internal testing, but specific country of origin or whether it was retrospective/prospective outside of the "real-time studies will be ongoing" comment is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a quality control product, not a diagnostic device requiring expert interpretation of results to establish a "ground truth" on patient data. The "ground truth" for a control would be its known characteristics and stability, which are determined by laboratory testing.
4. Adjudication Method for the Test Set
Not applicable. No "test set" in the sense of patient cases needing adjudication.
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-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a laboratory control product, not an algorithm.
7. The Type of Ground Truth Used
For the performance (stability) of this control device, the ground truth is established through laboratory testing and measurements to determine its chemical and immunological stability over time under specified storage conditions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device that requires a training set.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).