(6 days)
Liquichek Anti-RNP Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies.
Liquichek Anti-RNP 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.
This document describes a 510(k) submission for the Bio-Rad Liquichek Anti-RNP Control, EIA. This product is an unassayed quality control for monitoring enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies. As such, it is a quality control product, not a diagnostic device intended to directly measure patient analytes. Therefore, the traditional performance metrics and study designs (e.g., sensitivity, specificity, reader studies, etc.) typically associated with diagnostic devices are not applicable in this context.
Instead, the review focuses on establishing substantial equivalence to a predicate device, specifically the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit, in terms of its characteristics as a quality control material.
Given the nature of the device as a quality control, the following information is not provided in the document and is generally not required for this type of submission:
- A table of acceptance criteria and reported device performance (in the diagnostic sense).
- Sample size used for the test set or data provenance (as there isn't a "test set" of patient samples in the traditional sense).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "study" implicitly revolves around demonstrating that the Liquichek Anti-RNP Control, EIA is suitable for its intended use as a control, and its characteristics are comparable to an existing, legally marketed control or a device against which it can be benchmarked for substantial equivalence.
Acceptance Criteria and Device Performance (as inferred for a quality control device):
The acceptance criteria for a quality control device primarily focus on its composition, stability, and suitability for monitoring the intended assay. Based on the provided 510(k) summary, the device's performance is demonstrated by its substantial equivalence to the predicate device in terms of its intended use, form, matrix, storage conditions, and relevant analytes.
| Acceptance Criteria (for a Quality Control Device) | Reported Device Performance (Bio-Rad Liquichek Anti-RNP Control, EIA) |
|---|---|
| Intended Use: Monitoring EIA procedures for RNP autoantibodies. | Intended Use: An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of ribonucleoprotein (RNP) autoantibodies. (Matches predicate's broader use as an ANA screening test kit, but the Bio-Rad device is specifically an RNP control). |
| Form: Liquid. | Form: Liquid. (Substantially equivalent to predicate). |
| Matrix: Human Serum. | Matrix: Human Serum with added preservatives and stabilizers. (Substantially equivalent to predicate). |
| Levels: Provides appropriate control levels. | Levels: Negative, Positive, High Positive. (Predicate has Negative, Positive, Cutoff; Bio-Rad offers a "High Positive" for potentially broader monitoring). This difference does not negate equivalence for a control device. |
| Storage: Stable under specified storage conditions. | Storage: 2-8°C. (Substantially equivalent to predicate). |
| Analytes: Specific for RNP autoantibodies. | Analytes: Anti-RNP. (This defines its specificity as a control, aligning with the predicate's mention of SmRNP within its broader ANA panel, making it a suitable control for an RNP assay). |
| Open Vial Claim: Defined stability after opening. | Open Vial Claim: 30 Days at 2-8°C. (This provides specific shelf life information not explicitly detailed for the open vial predicate, but is a standard requirement for quality control materials). This demonstrates appropriate characterization of the control material, not a direct performance comparison against an identical predicate claim. |
The Study Proving the Device Meets Acceptance Criteria (as inferred from the 510(k) submission):
The "study" for this device is the process of comparing its characteristics and intended use to a legally marketed predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit) to establish substantial equivalence. The FDA's review and subsequent clearance (K984476) confirm that this comparison was satisfactory.
The provided information focuses on the descriptive aspects of the device and its comparison to the predicate rather than a clinical performance study. The key elements of this "study" are:
- Comparison Table: The document explicitly provides a table comparing the Bio-Rad Liquichek Anti-RNP Control, EIA with the Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit across critical parameters such as intended use, form, matrix, levels, storage, and analytes. This table serves as the primary evidence for demonstrating substantial equivalence.
- Product Description: A detailed description of the device's composition (human serum with preservatives and stabilizers, liquid form) is provided to ensure its suitability as a control.
- Intended Use Statement: The stated intended use for monitoring RNP autoantibody EIA procedures is clearly defined, demonstrating its specific application.
In summary, for a quality control device like the Liquichek Anti-RNP Control, EIA, "acceptance criteria" are met by demonstrating that its physical and chemical properties, as well as its intended use, are consistent with established good manufacturing practices for control materials and are substantially equivalent to a legally marketed predicate device used for similar purposes in an immunoassay setting. No clinical "performance" study on patient samples is presented or typically required 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).