(25 days)
Liquichek Anti-SS-B Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-B autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and the study details for the Liquichek™ Anti-SS-B Control, Positive, based on the provided document:
This document describes a new quality control device, and the "performance" referenced refers to its stability rather than diagnostic accuracy for patient samples. Therefore, typical metrics like sensitivity, specificity, or AUC based on clinical outcomes are not applicable.
Acceptance Criteria and Device Performance Study for Liquichek™ Anti-SS-B Control, Positive
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Claims) | Reported Device Performance (Study Results) |
|---|---|
| Open Vial Stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C. | The stability studies performed supported this claim. |
| Shelf Life: Control stable for 2 years when stored unopened at 2 to 8°C. | The stability studies performed supported this claim. Real-time studies are ongoing to support this claim. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical performance, as this is a quality control product. The performance studies relate to the stability of the control material itself.
- Sample Size: Not explicitly stated as a number of distinct "samples" in the traditional sense. The studies would have involved multiple aliquots or units of the control material tested over time.
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The data is retrospective in the sense that the studies were performed and data collected prior to this submission, but the "real-time studies will be ongoing" suggests a prospective element for shelf-life confirmation. Country of origin for data is implied to be within Bio-Rad's facilities, likely in the USA given the submission location (Irvine, California).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For a quality control material, the "ground truth" is defined by the stability of the analyte within the control. This is determined through chemical and immunological assays over time, not by expert interpretation.
4. Adjudication Method
Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or conflicting results in diagnostic studies. This is a stability study for a quality control product.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are used to evaluate the diagnostic performance of a device with and without AI assistance on human readers. This is a quality control product, not a diagnostic device for clinical use by human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a biochemical control, not an algorithm. Its performance is chemical/biological stability.
7. Type of Ground Truth Used
The ground truth for the stability studies would be analytical measurements of the Anti-SS-B autoantibodies' concentration or activity within the control over time, under specified storage conditions. These measurements would be compared against predefined acceptable ranges for stability.
8. Sample Size for the Training Set
Not applicable. This document describes a quality control product, not an AI/algorithm-based device that requires a training set. The "training" for this product involves its manufacturing process and subsequent stability testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" in the context of this chemical/biological quality control product. The product's intended performance (stability) is established through rigorous analytical testing and adherence to manufacturing specifications.
§ 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).