(23 days)
Liquichek anti-mitochondrial control, positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of mitochondrial autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Liquichek™ Anti-Mitochondrial Control, Positive:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Claims) | Reported Device Performance |
|---|---|
| Open vial stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C. | "Once the control is opened the analyte will be 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 2-8°C." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes stability studies. While it states that "Stability studies have been performed," it does not specify the sample size used for these tests. It also does not mention the country of origin of the data or whether the study was retrospective or prospective in the context of the stability studies. However, the mention of "Real time studies will be ongoing to support the shelf life of this product" implies a prospective nature for at least part of the shelf-life evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The product is a quality control material and the performance claim is about its stability, not diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set
This information is not provided as the device is a quality control material used for monitoring tests, not a diagnostic device requiring adjudication of results on patient samples.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or test results, often comparing AI-assisted vs. unassisted human performance. The Liquichek™ Anti-Mitochondrial Control is a quality control material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of "standalone" performance (algorithm only) is not applicable to this device. This is a quality control material, not an algorithm or an AI product. Its performance is assessed by its chemical/biological stability over time.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies would be the measured and confirmed stability of the anti-mitochondrial antibodies in the control material over the specified timeframes and storage conditions. This is likely determined through laboratory assays demonstrating consistent performance (e.g., maintaining a certain titer or reactivity level) of the control material over time.
8. The Sample Size for the Training Set
This product is a quality control material. It's not a machine learning model, so the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device.
§ 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).