(25 days)
Liquichek Anti-SS-A Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of SS-A 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 information for the Liquichek™ Anti-SS-A Control, Positive, based on the provided document:
This document describes a quality control product, not a diagnostic device that directly assesses patient conditions. Therefore, the typical "performance" metrics for a diagnostic device (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance criteria relate to the stability and consistency of the control material.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability | Analyte stable for 60 days when stored tightly capped at 2-8°C after opening. |
| Shelf Life (Unopened) | Control is stable for 2 years when stored unopened at 2-8°C. |
Study Details:
Based on the provided document, the study conducted is a stability study.
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "supporting data" and "real time studies" but doesn't provide specific sample numbers of control vials tested.
- Data Provenance: Not explicitly stated regarding country of origin. The study is described as "Real-time studies will be ongoing," which suggests a prospective study design for shelf life, and the open vial stability would also be prospective. All data is retained by Bio-Rad Laboratories.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable directly. This is a quality control product, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the inherent stability of the control material over time, measured through established laboratory assays.
3. Adjudication method for the test set:
- Not applicable as there's no diagnostic interpretation requiring adjudication.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is for evaluating observer performance with and without an assist device for diagnostic tasks.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
6. The type of ground truth used:
- The ground truth for this device's performance is the measured stability of the Anti-SS-A analyte within the control material over defined time periods (60 days open, 2 years unopened) when subjected to specific storage conditions. This would be determined by repeatedly testing the control material using accepted laboratory methods for Anti-SS-A detection and ensuring the results remain within a predefined acceptable range.
7. The sample size for the training set:
- Not applicable. This is a quality control product undergoing stability testing, not a machine learning algorithm that requires a training set.
8. How the ground truth for the training set was established:
- Not applicable. (See #7).
§ 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).