(18 days)
Liquichek Anti-Scl-70, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 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 the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Product 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." (Confirmed by stability studies.) |
| 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." (Confirmed by stability studies, with real-time studies ongoing to support this claim.) |
| Intended Use: For use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Scl-70 autoantibodies. | The device's intended use fully aligns with this claim. The 510(k) clearance confirms substantial equivalence for this intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the stability studies. It only mentions that "Stability studies have been performed..."
The data provenance is retrospective, as the studies have already been performed. The country of origin of the data is implicitly the United States, as Bio-Rad Laboratories is based in Irvine, California, and submitted the control for FDA approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study focuses on product stability and performance as a quality control, not on diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. The study is on the stability of a quality control product, not on diagnostic accuracy that would require human adjudication of results.
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 information is not applicable and therefore not provided. This device is an in-vitro diagnostic (IVD) quality control product, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided. This device is a quality control product; it does not involve an algorithm working independently. Its performance is related to its inherent stability as a biological reagent.
7. The Type of Ground Truth Used:
The "ground truth" for the stability studies is the measured concentration/activity of the Anti-Scl-70 analyte over time and under specified storage conditions. The studies assessed whether the analyte's characteristics remained within acceptable bounds given the stated storage parameters.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The device is a quality control material and does not involve a "training set" in the context of machine learning or predictive modeling.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore not provided, as 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).