(21 days)
The Liquichek™ ANA Control, Mitotic Spindle 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.
This document is a 510(k) Premarket Notification for a Liquichek™ ANA Control, Mitotic Spindle Pattern, Positive. It is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not a study performing clinical validation of a diagnostic algorithm or AI device. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a control device like this are primarily related to its stability, which ensures it functions reliably as a quality control material over time. The document doesn't provide specific quantitative performance metrics like sensitivity or specificity because it's a control, not a diagnostic test. Instead, its performance is described in terms of its stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open vial stability | 60 days when stored tightly capped at 2-8°C |
| Unopened shelf life | 2 years when stored unopened at 2-8°C |
| Equivalence to predicate device for stated intended use | Found substantially equivalent by FDA (K024231) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The stability studies would involve multiple units of the control material tested over time, but the exact number isn't provided.
- Data Provenance: The document states, "Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories." This indicates the studies were likely conducted internally by Bio-Rad Laboratories, presumably in a laboratory setting. The data is prospective for stability testing, as it tracks the product over its claimed shelf life. There is no information about country of origin beyond "Bio-Rad Laboratories 9500 Jeronimo Road, Irvine. California".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a quality control material. Its "ground truth" is its inherent characteristic (e.g., the presence of ANA Mitotic Spindle Pattern) which is established during its manufacturing and characterization, not by human experts interpreting clinical data.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the sense of patient samples requiring expert adjudication. The performance data relates to the stability of the control material itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a quality control device, not a diagnostic algorithm that would be used by human readers to interpret cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a laboratory control material, not an algorithm.
7. The Type of Ground Truth Used
For the characterization of the control material, the ground truth is its known composition and reactivity (presence of ANA Mitotic Spindle Pattern). This is established through the manufacturing process and internal quality assurance testing to ensure it consistently provides the expected reactive pattern. It is not based on expert consensus, pathology, or outcomes data in a clinical trial sense.
8. The Sample Size for the Training Set
Not applicable. As this is a control material, there is no "training set" in the context of machine learning or algorithm development. The manufacturing process and quality control methods are developed and refined over time based on internal laboratory practices and standards.
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).