(6 days)
Liquichek Anti-SS-A Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of SS-A autoantibodies.
Liquichek Anti-SS-A Control, EIA 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 text describes a 510(k) summary for the Bio-Rad Liquichek Anti-SS-A Control, EIA. This device is an unassayed quality control for monitoring enzyme immunoassay procedures. As such, the concept of "accuracy" or "performance" as typically applied to diagnostic or AI devices (e.g., sensitivity, specificity, AUC) does not directly apply in the same way.
The primary acceptance criteria for a quality control device largely revolve around its stability, consistency, and chemical composition, to ensure it can reliably perform its intended function of monitoring other assays. The document focuses on demonstrating substantial equivalence to a predicate device, which is the regulatory pathway for this type of product.
Therefore, many of the requested points regarding acceptance criteria, study design for performance, sample sizes for test sets, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable or directly addressed in the context of this specific product (quality control material).
Here's a breakdown of the information that can be extracted or inferred based on the nature of the device and the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As a quality control material, the "performance" isn't about diagnostic accuracy. Instead, the "acceptance criteria" relate to its characteristics for fulfilling its role as a control. The document implies these criteria are met by demonstrating substantial equivalence to the predicate.
| Characteristic | Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance (Liquichek Anti-SS-A Control, EIA) |
|---|---|---|
| Intended Use | For monitoring EIA procedures for SS-A autoantibodies. | Unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of SS-A autoantibodies. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Negative, Positive, High Positive | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Anti-SS-A | Anti-SS-A |
| Open Vial Claim | Defined shelf life after opening | 30 Days at 2-8°C |
| Preservatives | Stable, effective | Contains 0.1% sodium azide as a preservative. |
| Stabilizers | Stable | Contains stabilizers. |
Study to Prove Acceptance Criteria:
The study proving the device meets its "acceptance criteria" for substantial equivalence is the comparison to the predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, K954723) as detailed in the "Statement of How Technological Characteristics Compare to Substantial Equivalent Device" table. The FDA's 510(k) clearance signifies acceptance of this comparison.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This is not a diagnostic device requiring a test set of patient samples for performance evaluation (e.g., sensitivity/specificity). The evaluation focuses on the characteristics of the control material itself against a predicate.
- Data Provenance: Not applicable in the context of diagnostic performance data. The data provenance would relate to the manufacturing and characterization of the control material, which is implied to be from Bio-Rad Laboratories (Irvine, CA, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the sense of clinical diagnosis or pathology, is not established for a quality control material. The "ground truth" for this device is its defined composition and behavior as a control, established through internal characterization and comparison to a predicate.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" requiring adjudication in the context of a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often with AI assistance, and does not apply to a quality control material.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is not an algorithm, but a physical quality control reagent.
7. The Type of Ground Truth Used
- The "ground truth" for this quality control material is its defined composition and characteristics, and its demonstrated ability to function as a control for SS-A autoantibody detection, as established by the manufacturer and accepted by the FDA through the substantial equivalence process. This is implicitly based on laboratory characterization and comparison to the established predicate device.
8. The Sample Size for the Training Set
- Not applicable. This device is a biochemical control, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, 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).