(23 days)
The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
This document describes a submission for a medical device called "Liquichek™ Anti-nDNA Control, Positive" to the FDA for market clearance. It is not an AI/ML device, and therefore several of your requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the information that is available and noting where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Study | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | The device's intended use should be met. | The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies. This aligns with its classification as an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control. |
| Open Vial Stability | The analyte should remain stable for a specified period after opening. | Once the control is opened, the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C. |
| Shelf Life (Unopened) | The control should be stable for a specified period when stored unopened. | The control is stable for 2 years when stored unopened at 2-8°C. |
| Comparability to Predicate Device | The new device should be substantially equivalent to the predicate device in terms of intended use, matrix, and storage conditions. | The new device has identical intended use, human serum matrix, and unopened storage conditions (2°C to 8°C until expiration date) compared to the predicate device (Kallestad™ Autoantibody Positive Control, K780899A). Differences exist in opened stability (60 days liquid vs. 6 weeks/4 months reconstituted) and form (liquid vs. lyophilized), and in the specific analytes (Anti-nDNA only for new device vs. a broader panel for predicate). The FDA determined substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a quality control material and the studies described are stability studies, not performance studies on a clinical test set. The document does not describe "test sets" in the context of diagnostic accuracy. The studies were performed by Bio-Rad Laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a quality control product, not a diagnostic test that requires expert interpretation of results for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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/ML diagnostic algorithm. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical reagent, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the stability characteristics of the control material itself. This was established through real-time stability studies conducted by Bio-Rad Laboratories, which are likely laboratory measurements of the control's performance over time under specified storage conditions. The document states "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-nDNA Control, Positive." and "Real time studies will be ongoing to support the shelf life of this product."
8. The Sample Size for the Training Set
Not applicable. This device is a quality control product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above. The "ground truth" for the stability studies was established through laboratory testing and measurements.
§ 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).