(314 days)
The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal Pproteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-idermatomyositis, mixed connective tissue disease and Sjögren's syndrome, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) test kit is intended to be used in a clinical, reference or hospital laboratory. This kit is not designed for point-of-care testing.
The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) consists of antigen coated test strips, a positive control, alkaline phosphatase-labelled anti-human IgG conjugate, sample buffer concentrate, NBT/BCIP substrate solution, incubation tray and test instruction. Evaluation protocol, reaction control card as well as further accessories for use with EUROLineScan are available separately.
The EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) kit is an immune lineblot strip test intended for the qualitative detection of IgG class antibodies against nRNP/Sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, CENP B and ribosomal P-proteins in human serum. Detection of these antibodies is used as an aid in the diagnosis of autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, poly-/dermatomyositis, mixed connective tissue disease and Sjögren's syndrome, in conjunction with other laboratory and clinical findings.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on method comparison studies against predicate devices rather than explicit acceptance criteria with pre-defined thresholds for agreement. However, the tables provided demonstrate the agreement rates between the EUROIMMUN EUROLINE ENA Profile 9 Ag (IgG) and predicate ELISA kits (K123261 or K063565). The reported percentages of negative, positive, and overall agreement, along with 95% Confidence Intervals (C.I.), serve as the performance indicators.
Below is a summary of the reported agreement rates for each analyte from the "Method Comparison" section (refer to the document for full tables and 95% C.I.):
| Analyte | Positive Agreement (vs Predicate) | Negative Agreement (vs Predicate) | Overall Agreement (vs Predicate) |
|---|---|---|---|
| nRNP/Sm | 100.0% | 88.5% | 98.5% |
| Sm | 99.8% | 82.9% | 99.1% |
| SS-A | 97.6% | 99.5% | 98.1% |
| Ro-52 | 99.5% | 68.4% | 93.1% |
| SS-B | 96.7% | 96.9% | 96.9% |
| Scl-70 | 98.5% | 96.5% | 98.2% |
| Jo-1 | 97.6% | 100.0% | 97.8% |
| CENP B | 99.2% | 96.2% | 99.0% |
| Ribosomal P-proteins | 99.6% | 84.6% | 98.4% |
2. Sample size used for the test set and the data provenance:
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Sample Sizes for Method Comparison (Test Set):
- nRNP/Sm: 936 samples
- Sm: 917 samples
- SS-A: 1036 samples
- Ro-52: 276 samples
- SS-B: 1036 samples
- Scl-70: 663 samples
- Jo-1: 626 samples
- CENP B: 670 samples
- Ribosomal P-proteins: 615 samples
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Data Provenance: The samples were "clinically characterized samples obtained from different sources." Specific countries of origin are not detailed in the provided text. The nature of "clinically characterized samples" implies a retrospective collection from patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts or their qualifications for establishing the "clinical characterization" of the samples used in the method comparison and clinical studies. It mentions "clinically characterized samples," which typically implies diagnosis by medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify an adjudication method like 2+1 or 3+1 for the test set. The clinical characterization of samples is assumed to be the established reference.
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:
This is not applicable. The device is an in-vitro diagnostic (IVD) kit for antibody detection, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Its evaluation is based on agreement with predicate devices and clinical performance in detecting antibodies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A "standalone" performance study in the context of an algorithm without human-in-the-loop is not directly applicable here. The device itself is an assay (lineblot strip test). While it can be evaluated visually or by the EUROLineScan software, the performance results presented are for the kit's ability to detect antibodies and its agreement with predicate ELISA kits. The "analytical performance" section covers intra-assay, inter-assay, inter-lot, and inter-observer reproducibility, indicating that visual evaluation by humans plays a role, alongside potential software evaluation (EUROLineScan). However, the primary performance data refers to the assay's output itself, which is a qualitative positive/negative result for each antibody.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the method comparison studies was based on the results obtained from legally marketed predicate ELISA kits (EUROIMMUN Anti-nRNP/Sm ELISA (IgG), EUROIMMUN Anti-Sm ELISA (IgG), Inova Quanta Lite™ SS-A 52 ELISA, etc.). For the clinical studies section, the ground truth was "clinically characterized samples," meaning the diagnosis of autoimmune diseases (SLE, SSc, PM/DM, MCTD, Sjögren's, RA) and various control groups. This implies a clinical diagnosis, likely established by expert consensus based on symptoms, other laboratory findings, and possibly pathology where relevant to the disease.
8. The sample size for the training set:
The document does not explicitly mention a "training set" in the context of machine learning or algorithm development for this diagnostic kit. The performance data presented is for validation studies. For the clinical studies, a total of 1279 clinically characterized samples were investigated. For establishing the reference range, 173 samples from US asymptomatic blood donors were tested.
9. How the ground truth for the training set was established:
As no explicit "training set" for an algorithm is mentioned, this question is not directly applicable in the conventional sense for this device. If the EUROLineScan software has its own "training," that information is not detailed in this submission summary. For the assay itself, the "ground truth" during its development would align with the established scientific understanding of antibody presence in specific autoimmune diseases and the performance of existing, validated diagnostic methods.
§ 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).