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510(k) Data Aggregation
(237 days)
The EUROIMMUN Anti-nRNP/Sm ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against nRNP/Sm in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of mixed connective tissue diseases and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Sm ELISA (IgG) test kit is intended for the qualitative of IgG class autoantibodies against Sm in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-SS-A ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against SS-A in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of Sjögren's syndrome and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-SS-B ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against SS-B in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of Sjögren's syndrome and systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Scl-70 ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Scl-70 in human serum and plasma (EDTA, Li-heparin, Citrate), It is used as an aid in the diagnosis of progressive systemic sclerosis, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Centromeres ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Centromeres in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of limited form of progressive systemic sclerosis (CREST syndrome), in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-Jo-1 ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against Jo-1 in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of polymyositis and dermatomyositis, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG) test kit is intended for the qualitative determination of IgG class autoantibodies against ribosomal P-proteins in human serum and plasma (EDTA, Li-heparin, Citrate). It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.
The EUROIMMUN Anti-nRNP/Sm ELISA (IgG) consists of a microwell ELISA plate coated with nRNP/Sm antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-Sm ELISA (IgG) consists of a microwell ELISA plate coated with Sm antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-SS-A ELISA (IgG) consists of a microwell ELISA plate coated with SS-A antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate. TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-SS-B ELISA (IgG) consists of a microwell ELISA plate coated with SS-B antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-Scl-70 ELISA (IgG) consists of a microwell ELISA plate coated with Scl-70 antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-Centromeres ELISA (IgG) consists of a microwell ELISA plate coated with Centromeres antigen, calibrator, positive control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-Jo-1 ELISA (IgG) consists of a microwell ELISA plate coated with Jo-1 antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
The EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG) consists of a microwell ELISA plate coated with ribosomal P-proteins antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution.
Here's a breakdown of the acceptance criteria and study information for each of the EUROIMMUN ELISA kits for autoantibodies, as presented in the provided document.
It's important to note that the document outlines several ELISA kits (Anti-nRNP/Sm, Anti-Sm, Anti-SS-A, Anti-SS-B, Anti-Scl-70, Anti-Centromeres, and Anti-Jo-1, Anti-ribosomal P-proteins). Each kit has its own performance characteristics, and the requested information will be presented for each.
General Acceptance Criteria & Study Information (Applicable to all kits)
- Type of Test: Qualitative enzyme immunoassay (ELISA) for IgG class autoantibodies.
- Assay Cut-off: Ratio 1.0 (for all EUROIMMUN ELISA kits).
- Sample Types: Human serum and plasma (EDTA, Li-heparin, Citrate).
- Calibration: Relative evaluation/units.
- Ground Truth for Training/Testing: Clinically characterized samples. The document does not explicitly separate training and test sets with distinct ground truth methods for each. Instead, "comparison studies" utilize a test set of clinically characterized samples against a predicate device, and "clinical studies" evaluate performance against clinical diagnosis.
- Number of Experts to Establish Ground Truth: Not specifically mentioned for clinical characterization, but it's implied that clinical findings and diagnoses are established by medical professionals.
- Qualifications of Experts: Not explicitly stated, but assumed to be relevant medical specialists for the diagnoses of the conditions studied (e.g., rheumatologists, immunologists).
- Adjudication Method: Not explicitly mentioned. Clinical diagnoses are typically consensus-based among healthcare professionals or based on established diagnostic criteria.
- MRMC Comparative Effectiveness Study: No MRMC studies were performed in this context. The comparisons are between the new ELISA device and a predicate ELISA device (algorithm only, as they are immunoassay kits) and against clinical diagnoses (standalone performance).
- Standalone Performance: Yes, the clinical studies evaluate the standalone performance of the algorithm (the ELISA kit) in terms of clinical sensitivity and specificity against clinical diagnoses.
- Data Provenance: Samples were obtained from different sources from Europe and North America (retrospective, as they are "clinically characterized samples").
- Sample Size for Training Set: Not explicitly stated. The document focuses on performance characteristics and comparison/clinical studies with given sample sizes. It is common for ELISA development to use a subset of samples for initial optimization and cut-off determination, but specific "training set" sizes are not detailed in this regulatory summary.
1. EUROIMMUN Anti-nRNP/Sm ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against nRNP/Sm in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing mixed connective tissue diseases and systemic lupus erythematosus.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite RNP ELISA): |
| Overall agreement: 97.2% (95% C.I.: 94.6% - 98.8%) | |
| Positive agreement: 91.2% (95% C.I.: 83.4% - 96.1%) | |
| Negative agreement: 100.0% (95% C.I.: 98.1% - 100.0%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Mixed connective tissue diseases (MCTD): 100.0% (95% C.I.: 94.5% - 100.0%) (n=65) | |
| Systemic lupus erythematosus (SLE): 23.3% (95% C.I.: 19.2% - 27.7%) (n=404) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups, excluding myositis): |
| 99.3% (95% C.I.: 98.0% - 99.9%) (Total n=577, excluding myositis) | |
| Individual specificities: Rheumatoid arthritis (100.0%), Systemic sclerosis (100.0%), Sjögren's syndrome (97.7%), Other autoimmune diseases (98.4%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples with various ratios (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for 5/6 samples, one negative sample 97.5% negative (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, SS-A, SS-B, Scl-70, Jo-1, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-nRNP/Sm ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 85-109% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.99, Mean %recovery 101-105%, Range of %recovery 91-120% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=15 pairs each). Regression equations near ideal (intercept 0, slope 1). |
2. EUROIMMUN Anti-Sm ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against Sm in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing systemic lupus erythematosus.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite Sm ELISA): |
| Overall agreement: 95.9% (95% C.I.: 93.0% - 97.9%) | |
| Positive agreement: 84.1% (95% C.I.: 69.9% - 93.4%) | |
| Negative agreement: 98.0% (95% C.I.: 95.4% - 99.3%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Systemic lupus erythematosus (SLE): 11.4% (95% C.I.: 8.5% - 14.8%) (n=414) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 99.0% (95% C.I.: 97.9% - 99.6%) (Total n=622) | |
| Individual specificities: Rheumatoid arthritis (100.0%), Systemic sclerosis (100.0%), Sjögren's syndrome (100.0%), Polymyositis/dermatomyositis (100.0%), Mixed connective tissue diseases (86.7%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for 4/6 samples, one negative 97.5% negative, another 0% negative (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, nRNP/Sm, SS-A, Scl-70, Jo-1, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-Sm ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 90-111% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.99, Mean %recovery 99-103%, Range of %recovery 89-118% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=16 pairs each). Regression equations near ideal (intercept 0, slope 1). |
3. EUROIMMUN Anti-SS-A ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against SS-A in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing Sjögren's syndrome and systemic lupus erythematosus.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite SS-A ELISA): |
| Overall agreement: 96.1% (95% C.I.: 93.2% - 98.0%) | |
| Positive agreement: 92.8% (95% C.I.: 86.8% - 96.7%) | |
| Negative agreement: 98.3% (95% C.I.: 95.2% - 99.7%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Sjögren's syndrome: 73.9% (95% C.I.: 63.4% - 82.7%) (n=88) | |
| Systemic lupus erythematosus (SLE): 40.6% (95% C.I.: 35.8% - 45.6%) (n=404) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 94.8% (95% C.I.: 92.5% - 96.5%) (Total n=534) | |
| Individual specificities: Systemic sclerosis (92.6%), Polymyositis/dermatomyositis (91.4%), Rheumatoid arthritis (97.0%), Mixed connective tissue diseases (91.1%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for positive/negative samples (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, nRNP/Sm, Sm, Scl-70, Jo-1, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-SS-A ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 93-107% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.99, Mean %recovery 95-98%, Range of %recovery 85-104% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=16 pairs each). Regression equations near ideal (intercept 0, slope 1). |
4. EUROIMMUN Anti-SS-B ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against SS-B in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing Sjögren's syndrome and systemic lupus erythematosus.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite SS-B ELISA): |
| Overall agreement: 98.5% (95% C.I.: 96.3% - 99.6%) | |
| Positive agreement: 96.5% (95% C.I.: 90.0% - 99.3%) | |
| Negative agreement: 99.5% (95% C.I.: 97.1% - 100.0%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Sjögren's syndrome: 39.8% (95% C.I.: 29.5% - 50.8%) (n=88) | |
| Systemic lupus erythematosus (SLE): 13.9% (95% C.I.: 10.6% - 17.6%) (n=404) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 98.1% (95% C.I.: 96.6% - 99.1%) (Total n=534) | |
| Individual specificities: Rheumatoid arthritis (99.4%), Systemic sclerosis (95.1%), Polymyositis/dermatomyositis (98.7%), Mixed connective tissue diseases (93.3%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for positive/negative samples (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, nRNP/Sm, Sm, SS-A, Scl-70, Jo-1, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-SS-B ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 92-116% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.99, Mean %recovery 100-105%, Range of %recovery 78-116% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=16 pairs each). Regression equations near ideal (intercept 0, slope 1). |
5. EUROIMMUN Anti-Scl-70 ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against Scl-70 in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing progressive systemic sclerosis.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite Scl-70 ELISA): |
| Overall agreement: 100.0% (95% C.I.: 98.8% - 100.0%) | |
| Positive agreement: 100.0% (95% C.I.: 97.1% - 100.0%) | |
| Negative agreement: 100.0% (95% C.I.: 98.0% - 100.0%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Systemic sclerosis: 23.2% (95% C.I.: 18.4% - 28.6%) (n=280) | |
| Diffuse systemic sclerosis: 59.4% (95% C.I.: 48.9% - 69.3%) (n=96) | |
| Limited systemic sclerosis: 5.3% (95% C.I.: 2.0% - 11.2%) (n=113) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 99.8% (95% C.I.: 99.1% - 100.0%) (Total n=629) | |
| Individual specificities: Systemic lupus erythematosus (100.0%), Polymyositis/dermatomyositis (100.0%), Rheumatoid arthritis (99.4%), Sjögren's syndrome (100.0%), Mixed connective tissue diseases (100.0%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for positive/negative samples (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, nRNP/Sm, Sm, SS-A, SS-B, Jo-1, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-Scl-70 ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 86-109% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.98, Mean %recovery 96-101%, Range of %recovery 86-113% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=16 pairs each). Regression equations near ideal (intercept 0, slope 1). |
6. EUROIMMUN Anti-Centromeres ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against Centromeres in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing limited form of progressive systemic sclerosis (CREST syndrome).
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite Centromeres ELISA): |
| Overall agreement: 98.3% (95% C.I.: 96.1% - 99.5%) | |
| Positive agreement: 93.6% (95% C.I.: 85.7% - 97.9%) | |
| Negative agreement: 100.0% (95% C.I.: 98.3% - 100.0%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Systemic sclerosis: 37.5% (95% C.I.: 31.8% - 43.5%) (n=280) | |
| Diffuse systemic sclerosis: 7.3% (95% C.I.: 3.0% - 14.4%) (n=96) | |
| Limited systemic sclerosis: 74.3% (95% C.I.: 65.3% - 82.1%) (n=113) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 99.0% (95% C.I.: 97.8% - 99.6%) (Total n=597) | |
| Individual specificities: Systemic lupus erythematosus (99.4%), Polymyositis/dermatomyositis (100.0%), Rheumatoid arthritis (99.4%), Sjögren's syndrome (96.6%), Mixed connective tissue diseases (97.8%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for positive/negative samples (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, nRNP/Sm, Sm, SS-A, Scl-70, Jo-1, Rubella, Measles, HSV1, Borrelia) were negative in Anti-Centromeres ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 91-111% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.99, Mean %recovery 93-98%, Range of %recovery 83-108% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=16 pairs each). Regression equations near ideal (intercept 0, slope 1). |
7. EUROIMMUN Anti-Jo-1 ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against Jo-1 in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing polymyositis and dermatomyositis.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite Jo-1 ELISA): |
| Overall agreement: 99.3% (95% C.I.: 97.6% - 99.9%) | |
| Positive agreement: 98.5% (95% C.I.: 91.7% - 100.0%) | |
| Negative agreement: 99.6% (95% C.I.: 97.6% - 100.0%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Myositis (Polymyositis/dermatomyositis): 18.6% (95% C.I.: 13.2% - 25.2%) (n=177) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 99.6% (95% C.I.: 98.8% - 99.9%) (Total n=699) | |
| Individual specificities: Systemic lupus erythematosus (99.1%), Rheumatoid arthritis (99.4%), Systemic sclerosis (100.0%), Sjögren's syndrome (100.0%), Mixed connective tissue diseases (100.0%), Fibromyalgia (100.0%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for positive/negative samples (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (rib.P-P, nRNP/Sm, Sm, SS-A, SS-B, Scl-70, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-Jo-1 ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 91-122% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.98, Mean %recovery 95-103%, Range of %recovery 85-117% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=15 pairs each). Regression equations near ideal (intercept 0, slope 1). |
8. EUROIMMUN Anti-ribosomal P-proteins ELISA (IgG)
Intended Use: Qualitative determination of IgG class autoantibodies against ribosomal P-proteins in human serum and plasma (EDTA, Li-heparin, Citrate) as an aid in diagnosing systemic lupus erythematosus.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High correlation with Predicate Device | Method Comparison (vs. Inova Quanta Lite Ribosomal P ELISA): |
| Overall agreement: 95.9% (95% C.I.: 92.6% - 98.0%) | |
| Positive agreement: 100.0% (95% C.I.: 87.7% - 100.0%) | |
| Negative agreement: 95.3% (95% C.I.: 91.6% - 97.7%) | |
| Acceptable Clinical Sensitivity in target diseases | Clinical Sensitivity: |
| Systemic lupus erythematosus (SLE): 5.3% (95% C.I.: 3.3% - 8.1%) (n=376) | |
| Acceptable Clinical Specificity in control groups | Clinical Specificity (Total control groups): |
| 99.2% (95% C.I.: 98.0% - 99.8%) (Total n=500) | |
| Individual specificities: Polymyositis/dermatomyositis (98.7%), Rheumatoid arthritis (100.0%), Systemic sclerosis (100.0%), Sjögren's syndrome (98.2%), Mixed connective tissue diseases (97.8%), Other autoimmune diseases (100.0%), Borreliosis (100.0%) | |
| Good analytical precision (Intra-assay and Inter-assay) | Intra-assay reproducibility: 100% agreement for positive/negative samples (n=20 per sample) |
| Inter-assay reproducibility: 100% agreement for 5/6 samples, one negative 97.5% negative (n=40 per sample) | |
| Lot-to-lot reproducibility: High agreement reported, with expected classification (positive/negative) maintained across lots. | |
| No significant cross-reactivity with other autoantibodies | Cross-reactivity: All 30 sera positive for various other autoantibodies (nRNP/Sm, Sm, SS-A, Scl-70, Jo-1, centromeres, Rubella, Measles, HSV1, Borrelia) were negative in Anti-ribosomal P-proteins ELISA. |
| No significant interference from common interfering substances | Interference: Individual recovery within 84-115% for hemoglobin (up to 1000 mg/dl), triglyceride (up to 2000 mg/dl), bilirubin (up to 40 mg/dl), and rheumatoid factor (up to 500 IU/ml). |
| Equivalence across different plasma types vs. serum | Matrix comparison: Coefficients of determination (R²) >0.99, Mean %recovery 95-98%, Range of %recovery 79-107% (for EDTA, Li-heparin, Citrate plasma vs. serum, n=16 pairs each). Regression equations near ideal (intercept 0, slope 1). |
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(200 days)
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EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
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EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
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EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Siögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.
The provided text describes EliA™ CENP, EliA™ U1RNP, EliA™ Sm, EliA™ Ro, and EliA™ La immunoassays, which are intended for the semi-quantitative measurement of IgG antibodies to specific antigens in human serum and plasma to aid in the clinical diagnosis of various autoimmune diseases.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria
The document does not explicitly state numerical acceptance criteria for the devices (e.g., minimum sensitivity, specificity, accuracy thresholds). Instead, the method for demonstrating performance is through "comparability" and "substantial equivalence" to predicate devices. The "reported device performance" is summarized as supporting substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparability to predicate devices for all specified analytes. | Data supports that the new devices are substantially equivalent to the predicate devices. |
| Performance with clinically defined sera. | Results obtained for clinically defined sera support comparability. |
| Performance with samples from apparently healthy subjects (normal population). | Results obtained for samples from apparently healthy subjects support comparability. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states that the comparability of the new devices and predicate devices is supported by a "data set" that includes results obtained from:
- A comparison study between new and predicate devices.
- Clinically defined sera.
- Samples from apparently healthy subjects (normal population).
However, the specific sample sizes for these studies are not provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. The ground truth appears to be based on "clinically defined sera" and "samples from apparently healthy subjects," implying clinical diagnosis rather than expert interpretation of raw data for the immunoassay itself.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically for evaluating the performance of readers with and without AI assistance in interpreting diagnostic images or data. Since these devices are in-vitro diagnostic immunoassays, rather than AI-assisted interpretation tools, a MRMC comparative effectiveness study was not performed or described. Therefore, there is no effect size of human readers improving with AI vs without AI assistance. The study described is a comparison of the new devices against predicate devices and clinical samples.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The EliA™ system is described as a "fully integrated and automated system for immunodiagnostic testing" performed on ImmunoCAP® 100/ImmunoCAP® 250 instruments, which "include software for evaluation of test results." This implies that the device itself is the "algorithm" or automated test. The performance described (comparability to predicate, clinical samples, healthy subjects) is inherently the standalone performance of the device system.
7. Type of Ground Truth Used
The ground truth for the performance evaluation appears to be based on:
- Clinical diagnosis: "clinically defined sera" and diagnoses like scleroderma (CREST Syndrome), mixed connective tissue disease (MCTD), systemic lupus erythematosus (SLE), and Sjögren's syndrome.
- Healthy status: "samples from apparently healthy subjects (normal population)."
This is a form of clinical ground truth, derived from established medical diagnoses and healthy cohorts.
8. Sample Size for the Training Set
The document does not provide information on a separate "training set" sample size. For IVD devices, a dedicated "training set" in the machine learning sense is often not explicitly mentioned in this type of submission unless a new algorithm is being developed. The "calibration" of the device uses six WHO-standardized IgG Calibrators, but this is for assay calibration, not algorithm training data.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" for an algorithm in the machine learning context is not described, the method for establishing its ground truth is not applicable/not provided. The device calibration uses a set of six WHO-standardized IgG Calibrators.
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