(6 days)
Liquichek Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Scl-70 autoantibodies.
Liquichek Anti-Scl-70 Control, ElA 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 is a 510(k) summary for the Bio-Rad Liquichek Anti-Scl-70 Control, EIA. This document is a premarket notification to the FDA for a new medical device, demonstrating its substantial equivalence to a legally marketed predicate device.
Crucially, this document is for a quality control device, not a diagnostic device that detects a disease in a patient. As such, the typical acceptance criteria and study designs associated with diagnostic accuracy (e.g., sensitivity, specificity, clinical outcome studies) are not applicable here.
The "acceptance criteria" for a quality control device typically refer to its performance characteristics in monitoring an assay, such as stability, consistency, and expected range of values. The "study that proves the device meets the acceptance criteria" for a quality control product is usually an internal validation demonstrating these characteristics.
Based on the provided text, here's a breakdown of what can be inferred:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines "acceptance criteria" by comparing the characteristics of the new device (Liquichek Anti-Scl-70 Control, EIA) to its predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit). The goal is to show substantial equivalence, meaning the new device performs similarly and is as safe and effective for its stated intended use.
| Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Liquichek Anti-Scl-70 Control, EIA) |
|---|---|---|
| Intended Use | A qualitative enzyme immunoassay (EIA) for screening the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. | An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of Scl-70 autoantibodies. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Negative, Positive, Cutoff | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Total ANAs against: DNA (dsDNA, nDNA), Histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Scl-70, Jo-1, Centrometric antigens, Sera positive for Immunofluorescent (IFA) Hep-2 ANAs | Anti-Scl-70 |
| Open Vial Claim | Shelf life (general) | 30 Days at 2-8°C |
Important Note: The "acceptance criteria" here are not numerical performance targets like sensitivity/specificity. Instead, they are the structural and functional equivalence to the predicate device, for its role as a quality control. The key difference in "Intended Use" and "Analytes" highlights that while the new device is a control for a subset of what the predicate detects, it serves a similar function within the broader immunoassay context (monitoring).
The study that "proves" the device meets these criteria is the submission itself, which articulates these similarities to the FDA. For a quality control device, this typically involves internal validation testing by the manufacturer to ensure:
- The control material is stable and maintains its intended characteristics over its claimed shelf life (including open vial stability).
- It produces consistent and predictable results within the specified assay conditions.
- It can effectively monitor the performance of an anti-Scl-70 EIA.
The document does not provide details of these internal validation studies (e.g., specific protocols, raw data, or statistical analyses of stability or consistency). It simply states the characteristics.
The remaining information points are not directly applicable to a 510(k) submission for a quality control device and the level of detail provided in this type of regulatory document. This is because:
- 2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient samples in the way there would be for a diagnostic device. The "testing" would involve internal validation of the control material itself.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for a quality control material is established by its manufacturing process and characterization, not by expert interpretation of patient data.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is for AI-assisted diagnostic tools, not quality control reagents.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI algorithms, not a chemical control.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a quality control, the "ground truth" is its precisely characterized composition and reactivity, established by the manufacturer's own assays and reference methods. It's an internal standard, not an external clinical marker.
- 8. The sample size for the training set: Not applicable. There is no "training set" for a quality control material in the context of machine learning.
- 9. How the ground truth for the training set was established: Not applicable for the same reason.
In summary, this 510(k) document establishes substantial equivalence for a quality control product by demonstrating similar characteristics and intended use to a predicate quality control product. The detailed performance studies typically seen for diagnostic devices (especially those involving AI) are not present or required here.
§ 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).