(6 days)
Liquichek ENA Control, EIA Screen is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the screening of extractable nuclear antigen (ENA) autoantibodies.
Liquichek ENA Control, EIA Screen is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided document is a 510(k) summary for the Bio-Rad Liquichek ENA Control, EIA Screen, a quality control device. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested fields cannot be filled as they are not applicable to this type of submission.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. The document focuses on comparing the technological characteristics of the Bio-Rad Liquichek ENA Control, EIA Screen to its predicate device, the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, to establish substantial equivalence as a quality control. It does not present specific performance criteria or results of a study to demonstrate the performance of the Bio-Rad device itself against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a study involving a test set of patient samples for performance evaluation. The "test set" in the context of a quality control device would typically refer to the stability or value assignment studies, but this information is not detailed here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment with experts is usually associated with diagnostic devices, where expert consensus or pathological findings are used to define the true positive/negative status of a sample. For a quality control material, the ground truth relates to its assigned values and stability, which are determined through manufacturing and validation processes, not expert review of patient cases.
4. Adjudication method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often assisted by AI, to assess the impact of the AI on reader performance. The Liquichek ENA Control, EIA Screen is a quality control material, not a diagnostic device that humans interpret in a clinical setting.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for a quality control material like the Liquichek ENA Control, EIA Screen would be its assigned values (Negative, Positive, High Positive) for monitoring enzyme immunoassay procedures. These values are established through rigorous manufacturing and validation processes by the manufacturer, rather than expert consensus, pathology, or outcomes data related to patient diagnosis.
8. The Sample Size for the Training Set
Not applicable. The device is a quality control material, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 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).