(25 days)
The Liquichek™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
The given document is a 510(k) premarket notification for a quality control device, not a diagnostic device that performs a clinical assessment. Therefore, the questions related to clinical performance, such as sensitivity, specificity, reader studies, and ground truth establishment in a clinical context, are not applicable. The device in question is a control material for laboratory testing.
Here's an analysis based on the provided information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are related to its stability as a quality control material.
| Acceptance Criteria (Product Claims) | Reported Device Performance (from Stability Studies) |
|---|---|
| Once opened, the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C. | The stability studies performed support this claim. |
| The control is stable for 2 years when stored unopened at 2 - 8°C. | The stability studies performed support this claim. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific "sample size" in terms of a number of patient samples for a test set, as this is a quality control material, not a diagnostic test for patient samples. The "test set" in this context refers to batches of the control material subjected to stability testing. The document states "Stability studies have been performed," providing no specific number of batches or samples used in these studies.
The data provenance is from Bio-Rad Laboratories, located in Irvine, California, USA. The studies would be prospective as they are "Real time studies" designed to establish stability over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. For a quality control material, "ground truth" typically refers to its known stability characteristics, which are determined through laboratory testing and analytical protocols, not by expert consensus on clinical findings.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations of patient data. This device is a lab control, and its performance is assessed via analytical stability studies, not clinical interpretation.
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
This question is not applicable. MRMC studies are for evaluating diagnostic devices that rely on human interpretation, often with AI assistance, for clinical cases. This device is a quality control material for laboratory instruments/assays.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical control material, not an algorithm or a software-based diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a quality control material is its chemical and physical stability over time, which is established through rigorous analytical testing under various conditions (e.g., temperature, light exposure) and measured against predefined specifications for the analytes it controls. The document states that "Stability studies have been performed," implying this type of analytical testing.
8. The sample size for the training set
This question is not applicable. The concept of a "training set" applies to machine learning models, which is not relevant for this physical quality control material.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as above.
§ 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).