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510(k) Data Aggregation
(260 days)
QUANTA Flash® Scl-70 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Scl-70 autoantibodies in human serum. The presence of anti-Scl-70 autoantibodies, in conjunction with clinical findings and other laboratory tests, aids in the diagnosis of systemic sclerosis.
QUANTA Flash® Scl-70 Calibrators are intended for use with the QUANTA Flash® Scl-70 chemiluminescent immunoassay for the determination of IgG anti-Scl-70 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.
QUANTA Flash® Scl-70 Controls are intended for use with the OUANTA Flash® Scl-70 chemiluminescent immunoassay for quality control in the determination of IgG anti-Scl-70 autoantibodies in human serum.
The QUANTA Flash Scl-70 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash Scl-70 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.
Recombinant Scl-70 is coated onto paramagnetic beads. The bead suspension is lyophilized and stored in the bead tube. Prior to use in the BIO-FLASH system, the sealed reagent tubes are pierced with the reagent cartridge lid and the beads are rehydrated and resuspended using resuspension buffer by pipetting up and down with a transfer pipette. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. A patient serum sample is prediluted 1:23.5 by the BIO-FLASH with system rinse in a disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(III) coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-Scl-70 antibodies bound to the corresponding Scl-70 on the beads.
For quantitation, the QUANTA Flash Scl-70 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash Scl-70 Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU)mL from the instrument signal (RLU) obtained for each sample.
Here's a summary of the acceptance criteria and study findings based on the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Total %CV values within 10%. | All total %CV values for 13 samples across various concentrations were within 10%. (Range: 3.4% - 5.9%) |
| Reproducibility (Between sites) | All %CV values within 15%. | All %CV values for 8 samples across three sites were within 15%. (Range: 1.3% - 8.3%) |
| Reproducibility (Between lots) | All %CV values within 10%. | All %CV values for 8 samples across three different lots were within 10%. (Range: 1.5% - 9.6%) |
| Limit of Quantitation (LoQ) | Total error (TE) < 25% (accuracy goal). | LoQ is 1.2 CU, meeting the accuracy goal. |
| Limit of Detection (LoD) | Proportions of false positives (alpha) < 5% and false negatives (beta) < 5%. | LoD is 0.2 CU, determined with alpha and beta less than 5%. |
| Limit of Blank (LoB) | Not explicitly stated as a separate criterion, but derived from method. | LoB is 0.1 CU. |
| Analytical Measuring Range (AMR) | Defined by LoQ and highest Master Curve Standard. | 1.2 CU - 786.3 CU. |
| Auto-rerun function | % recovery values for auto-rerun results compared to manual dilution within ± 20%. | % recovery values for auto-rerun were 104%, 101%, and 91% (average 102%), all within ± 20%. |
| Linearity | 80%-120% recovery, 0.9-1.1 slope, and ≥0.95 R² for linear regression analysis. | Percent recovery for all data points ranged from 80.2% to 118.4%. Slopes for individual samples ranged from 0.96 to 1.03 (all within 0.9-1.1). R² values for all samples were 0.99 or 1.00 (all ≥0.95). Combined results: Slope 1.01, R² 0.99. |
| Interference | 85% - 115% recovery for unit values. | No interference detected. Recoveries for Bilirubin (88-101%), Hemoglobin (93-105%), Triglycerides (89-97%), Cholesterol (93-106%), Human IgG (90-109% or < 4 CU), RF IgM (97-111%), Prednisone (100.0-109.7%), and Naproxen (97.7-109.7%) were all within the 85-115% range. |
| Sample Stability | 90-110% average recovery compared to control (Day Zero, 2-8°C). | All samples fulfilled acceptance criteria at each time point (up to 21 days at 2-8°C, up to 48 hours at room temperature, up to 3 freeze/thaw cycles). |
| Reagent Stability (Accelerated) | Microparticles: 95% CI of regression line between 85-115% at 2 weeks, no individual data point outside 75-125% recovery at 2 weeks. Controls & Calibrators: Lower 95% CI of regression line between 90-110% at 2 weeks, no individual data point outside 80-120% recovery at 2 weeks. | All components tested fulfilled the acceptance criteria, leading to a one-year expiration dating assignment. |
| Reagent Stability (Real-time) | Controls: Results within established acceptable ranges. Calibrators: % recovery of average of triplicates between 85-115%, %CV of triplicates < 10%. Reagent Cartridge: %CV of replicates < 15%, % recovery of each sample between 80-120%. | All results were within the acceptance limits for controls, calibrators, and reagent cartridges up to 6 months. |
| In-use Stability (Calibrators) | 5 successful calibrations in 8.5 hours, Calibrator average RLU recovery 90-110% compared to first use. | 5 successful calibrations performed over 8.5 hours. Calibrator RLU values remained within 90-110% range. Patient samples ran within expected range. Supports claim of up to 4 calibrations over 8 hours. |
| In-use Stability (Controls) | Replicates run within established range, linear regression line of %recovery vs. runs between 85-115% at run 15. | Low and High Controls ran within their acceptable range for all runs. Linear regression line of %recovery for both controls was within 85-115% at run 15. Supports claim of up to 15 uses. |
| In-use Stability (Reagent Cartridge) | Stability claim precedes 95% CI of regression line reaching 85% or 115% recovery OR 2 data points or ≥2% of recovery data is ≤ 75% or ≥ 125% recovery. | In-use (onboard) stability of 60 days was set. (Implies criteria were met up to that point). |
| Clinical Sensitivity (SSc) | Not explicitly stated as a numerical acceptance criterion, but validation sought to demonstrate performance. | 42.3% (95% CI: 33.9% - 51.1%) |
| Clinical Specificity (Controls) | Not explicitly stated as a numerical acceptance criterion, but validation sought to demonstrate performance. | 98.7% (95% CI: 96.9% - 99.4%) |
| Overall Agreement with Predicate | Not explicitly stated as a numerical acceptance criterion (e.g., >X%). However, the comparison aimed to show substantial equivalence. | Total Agreement: 97.6% (95% CI: 95.9% – 98.6%) for all 539 samples. Agreement within AMR (193 samples): Negative Agreement = 93.3% (95% CI: 88.1% – 96.3%), Positive Agreement = 95.5% (95% CI: 84.9% – 98.7%), Total Agreement = 93.8% (95% CI: 89.4% – 96.4%). |
2. Sample Size Used for the Test Set and Data Provenance
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Clinical Performance (Validation Set):
- Sample Size: 498 samples.
- Data Provenance: The text does not explicitly state the country of origin. It indicates the samples were a "separate set of samples, none of which were used in establishing the reference range." The patient groups include Systemic Sclerosis (SSc) and various control groups (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathy, Mixed Connective Tissue Disease, Celiac disease, Autoimmune thyroiditis, Sjögren's syndrome, Infectious disease, Crohn's disease, Osteoarthritis, COPD, Chronic Kidney Disease, Vasculitis, Raynaud's, Diabetes, Asthma, Skin Disease). The infectious disease samples specify Hepatitis C virus, Epstein-Barr virus, Toxoplasmosis, Cytomegalovirus, Mycoplasma infection, and Borrelia virus. The study is presented as evidence for the device's performance, suggesting prospective collection or a well-characterized retrospective cohort.
-
Comparison with Predicate Device:
- Sample Size: 539 samples (the 498 samples from the Validation Set plus 41 additional contrived samples).
- Data Provenance: Same as the clinical performance validation set, with additional contrived samples (diluted Scl-70 positive serum with negative serum).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing the ground truth for the clinical diagnosis of systemic sclerosis (SSc) or other conditions used in the clinical validation set. It simply refers to "Diagnosis" in the tables relating to sensitivity and specificity. Given this is an in vitro diagnostic device, the ground truth for clinical conditions would typically be established by clinical diagnosis by treating physicians, potentially corroborated by other clinical and laboratory findings.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth diagnoses in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an automated chemiluminescent immunoassay; therefore, human reader assistance and improvement with AI assistance are not applicable. The comparison is between the new automated device and a predicate ELISA (enzyme-linked immunosorbent assay), not human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire document describes the standalone performance of the QUANTA Flash® Scl-70 assay system (algorithm/device only without human-in-the-loop performance, as it's an automated immunoassay) across various analytical and clinical characteristics. The clinical sensitivity and specificity are direct measures of this standalone performance.
7. Type of Ground Truth Used
- Clinical Performance (Sensitivity/Specificity): The ground truth was clinical diagnosis. For systemic sclerosis (SSc), this means patients diagnosed with SSc. For control groups, this refers to patients diagnosed with other autoimmune diseases or infectious diseases, or healthy individuals.
- Analytical Performance: Ground truth was established by controlled experimental conditions, such as known concentrations for precision, linearity, and interference studies, or controlled conditions for stability studies.
- Comparison with Predicate Device: The ground truth for this comparison was the result obtained from the legally marketed predicate device, QUANTA Lite® Scl-70 ELISA.
8. Sample Size for the Training Set
- Reference Range Establishment (for Cut-off): 254 subjects were used. The sample groups included individuals with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Hashimoto's Thyroiditis, Hepatitis B Virus, Hepatitis C Virus, Inflammatory Bowel Disease, Drug Induced Lupus, Autoimmune atrophic gastritis, Biliary anastomatic stricture, and Healthy Individuals.
- Cut-off Adjustment: 19 systemic sclerosis samples that were positive on the predicate device were also used to aid in the final determination of the cutoff.
- The document does not explicitly describe a separate "training set" in the context of machine learning, as this is an immunoassay, but rather samples used for establishing the reference range/cut-off.
9. How the Ground Truth for the Training Set was Established
- Reference Range Establishment: The ground truth for the 254 subjects used to establish the reference range was based on their clinical diagnosis (e.g., Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Healthy Individuals).
- Cut-off Adjustment: The additional 19 systemic sclerosis samples had a ground truth based on their positive results on the predicate device (QUANTA Lite® Scl-70 ELISA) and their clinical diagnosis of systemic sclerosis.
The cut-off was established in accordance with CLSI C28-A3c ("Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition") and adjusted based on the results from the SSc samples positive on the predicate device to optimize differentiation.
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(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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