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EliA SmDP-S is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP-S uses the EliA IgG method.

The EliA SmD -S is a semi-quantitative solid-phase fluoroimmunoassay, for the determination of autoantibodies against Sm. The EliA SmDP-S test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EliA SmDP-S device are not explicitly stated as distinct criteria with numerical targets in the provided document. Instead, the document presents performance characteristics that implicitly serve as acceptance criteria by demonstrating that the device is substantially equivalent to a predicate device. Below is a summary of the reported device performance for key analytical and clinical characteristics.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):
  • Sample Size: A total of 628 patient samples were initially tested in the method comparison study with the predicate device. For statistical analyses, 460 samples were used after excluding 168 values outside the measuring range.
  • Data Provenance: Not explicitly stated, but typically such studies involve samples collected from various clinical sites. It is implied to be clinical patient samples, likely retrospective given they were previously collected for comparison.
• Test Set (Clinical Sensitivity and Specificity):
  • Sample Size: 328 clinically defined samples: 104 with Systemic Lupus Erythematosus (SLE) and 224 disease controls (Mixed connective tissue disease, Sjögren's syndrome, Scleroderma, Polymyositis/Dermatomyositis, Rheumatoid arthritis, Graves' disease, Hashimoto's disease, Bacterial infections, Viral infections).
  • Data Provenance: Not explicitly stated, but implied to be from clinical settings for diagnosed patients and controls. Likely retrospective.
• Reference Range/Expected Values:
  • Sample Size: 632 apparently healthy subjects.
  • Data Provenance: Sera obtained from a blood bank, equally distributed by age and gender, from Caucasian, African American, Hispanic and Asian populations.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth for clinical sensitivity and specificity was based on "clinically defined samples with a diagnosis". This implies that the diagnosis was established by medical professionals (e.g., rheumatologists, infectious disease specialists) based on a comprehensive clinical assessment, which would include other laboratory and clinical findings. The document does not provide details on the number or specific qualifications (e.g., years of experience) of these clinicians or specialists.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth of the test set samples. The samples were "clinically defined with a diagnosis" or "apparent healthy subjects," implying that their disease status or health status was established through standard clinical practice/diagnostic criteria rather than a specific expert adjudication process for the purpose of this study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is an in vitro diagnostic (IVD) immunoassay, which typically does not involve human readers interpreting results in the same way imaging devices do. The performance evaluation focuses on the analytical and clinical accuracy of the assay itself compared to a predicate device and clinical diagnoses, not on human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The entire document describes the performance of the EliA SmDP-S device as an in vitro diagnostic assay, which functions independently (algorithm only) to measure IgG antibodies. There is no human-in-the-loop component described for its operation or result generation. The device produces a semi-quantitative measurement (EliA U/mL) that is then interpreted based on defined cut-offs.

7. Type of Ground Truth Used

• For Method Comparison: The ground truth was the result obtained from the predicate device (EliA SmDP assay) for common patient samples.
• For Clinical Sensitivity and Specificity: The ground truth was based on "clinically defined diagnoses" of patients with Systemic Lupus Erythematosus (SLE) and various disease controls. This implies a diagnosis established through standard clinical criteria, which would include medical history, physical examination, other laboratory tests, and imaging findings (i.e., clinical diagnosis/outcomes data).
• For Reference Range: The ground truth was a group of "apparently healthy subjects."

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. For IVD devices like this, the development process usually involves internal validation and optimization batches, but not typically a formally labeled "training set" in the sense of machine learning. The studies described are primarily for validation and verification of the final device performance.

9. How Ground Truth for Training Set was Established

As no explicit "training set" is mentioned, the method for establishing its ground truth is also not detailed. However, for the development and optimization of such assays, ground truth for sample panels would typically be established using confirmed clinical diagnoses, reference methods, or well-characterized reference materials, similar to how the validation samples' ground truth was established using clinical diagnoses and predicate device comparisons.

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EliA CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA CENP uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA U1RNP uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA RNP70 uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K082759 (EliA CENP and EliA U1RNP) and K083117 (EliA RNP70), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells:

• EliA CENP Wells are coated with human recombinant centromere protein B 2 carriers (12 wells each), ready to use;
• -EliA U1RNP Wells are coated with human recombinant RNP (RNP70, A. C) proteins- 4 carriers (12 wells each), ready to use;
• -EliA RNP70 Wells are coated with human recombinant RNP (70 kDa) protein-4 carriers (12 wells each), ready to use;

EliA Sample Diluent:

• -EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use:

EliA IgG reagents:

• EliA IgG Coniugate 50 or 200: ß-Galactosidase labeled anti-laG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide -6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
• EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
• EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.

The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA CENP, EliA U1RNP and EliA RNP70 tests.

The provided FDA 510(k) summary for the EliA CENP, EliA U1RNP, and EliA RNP70 Immunoassays on the Phadia 2500/5000 instrument describes analytical performance studies, not typically studies involving human readers or expert adjudication in the context of AI/ML devices. Therefore, several of the requested sections below are marked as "Not Applicable (N/A)" because this document pertains to an in vitro diagnostic (IVD) assay and instrument combination, not an AI/ML-driven imaging or diagnostic device requiring human reader studies or expert adjudication of image-based ground truth.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for EliA CENP, EliA U1RNP, and EliA RNP70 Immunoassays on Phadia 2500/5000

The acceptance criteria for this device are demonstrated through various analytical performance metrics, primarily comparing the new instrument platform (Phadia 2500/5000) to a predicate device (Phadia 250). The performance data below focuses on precision, linearity, detection limits, and method comparison.

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "acceptance criteria" through the results of pre-specified analytical performance studies (precision, linearity, and method comparison), demonstrating the new device's equivalence to the predicate. The "acceptance criteria" are explicitly stated for the method comparison as "the slope for the regression lines should be 0.9 - 1.1 for single replicate to single replicate and intercept close to 0." For Other performance characteristics, the "acceptance" is implied by the presentation of the results, indicating they met the manufacturer's internal standards for demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Method Comparison): More than 100 samples for each EliA test (CENP, U1RNP, RNP70).
• Sample Size (Precision): 5 different samples were tested for each immunoassay. Each sample was tested in four replicates/run, over 21 runs (3 instruments x 7 runs), resulting in 84 replicates per sample.
• Sample Size (Linearity): Four patient serum samples were diluted for each immunoassay.
• Sample Size (Detection Limit): One blank sample (66 determinations) and three low-level samples (66 determinations) were used for LoD/LoQ studies for each immunoassay.
• Sample Size (Expected Values/Reference Range): 400 serum samples from an apparently healthy Caucasian population for each immunoassay.
• Data Provenance: The document does not explicitly state the country of origin for the patient samples, but the reference populations for "Expected Values" are described as "Caucasian population obtained from a blood bank." The studies described appear to be prospective analytical studies conducted by the manufacturer to support the 510(k) submission for the new instrument platform.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• N/A. This is an IVD device measuring antibody levels, not an AI/ML device that requires expert human interpretation of images or clinical data for ground truth. The "ground truth" for these tests is the value measured by the predicate device and the analytical standards (e.g., linearity standards, controls).

4. Adjudication Method for the Test Set

• N/A. No expert adjudication process is described as this is an IVD device.

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

• N/A. This is an IVD device, not an AI-assisted diagnostic tool involving human readers of images or other complex data. The comparison is between an older instrument (Phadia 250) and a new instrument (Phadia 2500/5000) running the same assays.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• N/A. This is an IVD device, not an AI algorithm. The performance described is the standalone analytical performance of the instrument/assay combination.

7. The Type of Ground Truth Used

• For the method comparison studies, the "ground truth" or reference method was the predicate device (Phadia 250 instrument) running the same assays. The goal was to show substantial equivalence between the new and predicate instruments.
• For analytical performance characteristics (precision, linearity, detection limits), the ground truth is established through standard laboratory practices using calibrators, controls, and reference materials as per CLSI guidelines, which are themselves traceable to established measurement procedures.

8. The Sample Size for the Training Set

• N/A. This document describes performance validation of an IVD assay/instrument system, not the training of an AI/ML model. Therefore, there is no "training set" in the AI/ML sense. The device is a measurement system; it does not "learn" from data.

9. How the Ground Truth for the Training Set Was Established

• N/A. As there is no AI/ML training set, this question is not applicable. The device's "ground truth" (its measurement accuracy) is established through rigorous analytical validation studies using controls, calibrators, and comparison to validated predicate methods, not through a "training set" of patient data.

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EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 250.

EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA anti-TPO Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroid peroxidase (TPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TPO uses the EliA IgG method on the instrument Phadia 250.

EliA anti-TPO Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroid peroxidase (TPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TPO uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA Thyroid Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies against thyroid peroxidase (TPO) and thyroglobulin (TG) with Phadia 250 using the EliA IgG method.

EliA Thyroid Positive Control 2500/5000 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies against thyroid peroxidase (TPO) and thyroglobulin (TG) with Phadia 2500/5000 using the EliA IgG method.

The method specific reagents on Phadia® 250 and Phadia® 2500/5000 are identical: they are only filled in different containers. Each device consists of:

• EliA anti-TG wells are coated with a human thyroglobulin antigen 4 carriers (16 wells each), ready to use; or EliA anti-TPO wells are coated with a human recombinant thyroid peroxidase
• antigen 4 carriers (16 wells each), ready to use; EliA Sample Diluent: PBS containing BSA, detergent and 0.095% sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
• -EliA IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% sodium azide - 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
• -EliA Thyroid Positive Control 250 or 2500/5000: Human serum containing IqG antibodies to TG and TPO in PBS containing BSA, detergent and 0.095% sodium azide - 6 single use vials, 0.3 mL each, ready to use;
• EliA Negative Control 250 or 2500/5000: Human sera from healthy donors in -PBS containing BSA, detergent and 0.095% sodium azide - 6 single-use vials, 0.3 mL each, ready to use;
• -EliA IgG Calibrator Strips: Human IqG (0, 4, 10, 20, 100, 600 µq/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• -EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• -EliA IqG Calibrator Well: Coated with mouse monoclonal antibodies - 4 carriers (12 wells each), ready to use.

The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages except the positive and negative controls are required to carry out an EliA anti-TG or anti-TPO test.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a formal table with pass/fail values. Instead, the document presents performance characteristics and demonstrates that the device meets these characteristics, implying they are the de facto acceptance criteria. I will infer these criteria from the studies conducted.

EliA anti-TG Immunoassay

EliA anti-TPO Immunoassay

2. Sample Size Used for the Test Set and Data Provenance

• Precision/Reproducibility:
  • EliA anti-TG/TPO on Phadia 250/2500/5000: 8 samples, each with 252 replicate determinations (21 runs x 3 instruments x 7 runs each over 7 days).
  • Data Provenance: Not explicitly stated, implied to be internal lab studies.
• Linearity/Assay Reportable Range:
  • EliA anti-TG/TPO on Phadia 250/2500/5000: 6-7 patient serum samples.
  • Data Provenance: Not explicitly stated, implied to be internal lab studies.
• Detection Limit (LoB/LoD):
  • EliA anti-TG/TPO on Phadia 250/2500/5000: Four analyte-free samples and four low antibody concentration blood donor samples. Each measured in 36 replicates (6 replicates x 6 runs). Total of 8 samples x 36 replicates = 288 measurements.
  • Data Provenance: Not explicitly stated, implied to be internal lab studies using blood donors.
• Endogenous Interference:
  • EliA anti-TG/TPO: Three serum samples (one negative, one near cut-off, one high positive). Each spiked with different interfering substances or blanks and analyzed in triplicates. Runs repeated twice.
  • Data Provenance: Not explicitly stated, implied to be internal lab studies.
• Reference Sera:
  • EliA anti-TG: 8 samples from CAP.
  • EliA anti-TPO: 8 samples from CAP and 12 samples from UK-NEQAS.
  • Data Provenance: External proficiency testing programs (CAP, UK-NEQAS).
• Carry-over:
  • Phadia 250: A serum sample (diluted 1:2 and 1:20). Tested with EliA Ro (another assay) to demonstrate instrument's general carry-over performance.
  • Data Provenance: Not explicitly stated, implied to be internal lab studies.
• Assay Cut-off / Expected Values:
  • EliA anti-TG/TPO: 604 apparently healthy blood donor samples.
  • Data Provenance: Caucasian, African American, Hispanic, and Asian individuals, almost equally distributed by sex and age. (Source country not specified but "blood donor samples" are typically collected prospectively for such studies).
• Method Comparison and Clinical Sensitivity/Specificity:
  • EliA anti-TG/TPO: 718 serum samples from patients with various thyroid and autoimmune conditions (Graves' disease, autoimmune thyroiditis, non-AI thyroid disease, connective tissue disease, Crohn's disease, ulcerative colitis, primary biliary cirrhosis, HIV, HCV, HBV, other infection, cancer, rheumatoid arthritis, hypergamma-globulinemia, systemic lupus erythematosus, Sjögren's syndrome, celiac disease, type 1 diabetes mellitus, type II diabetes mellitus, pregnant women of all trimesters, pre-eclampsia, miscarriage, thyroid cancer, myasthenia gravis, pernicious anemia, chronic lymphocytic thyroiditis, sub-acute thyroiditis, multi-nodular goiter).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
• Matrix Comparison:
  • EliA anti-TG/TPO: 57 patients from whom serum, lithium heparin plasma, and EDTA plasma were collected.
  • Data Provenance: Not explicitly stated, implied to be patient samples.

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 use of "experts" in the context of diagnostic performance studies. For immunoassay devices like these, ground truth is typically established by:

• Reference Methods: Comparison to a legally marketed predicate device (VarelisA TG Antibodies, VarelisA TPO Antibodies) as seen in the method comparison study.
• Clinical Diagnosis: For sensitivity and specificity, samples are categorized based on "diagnosis" (e.g., Graves' disease, autoimmune thyroiditis). This implies a clinical ground truth, but the details of how these diagnoses were established (e.g., by how many clinicians, their specialties, or experience levels) are not provided.
• External Reference Sera: For reference sera evaluation, targets are established by external institutions like CAP and UK-NEQAS, which rely on peer groups or provider definitions.

Therefore, there's no mention of a specific number of experts or their qualifications establishing ground truth in the way one might see for image-based diagnostics.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for establishing ground truth, such as 2+1 or 3+1 expert consensus. Instead, it relies on established clinical diagnoses for sensitivity/specificity studies and predicate device results for method comparison.

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

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool for human readers. Its performance is evaluated intrinsically and in comparison to a predicate device, not in terms of human reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a standalone immunoassay system (EliA anti-TG Immunoassay and EliA anti-TPO Immunoassay run on Phadia 250/2500/5000 instruments). Its performance is inherently "standalone" in the sense of being an automated laboratory test without direct human interpretive input at the point of result generation. Results are quantitative values that clinicians interpret. Therefore, the entire analytical and clinical performance section describes the device's standalone performance.

7. The Type of Ground Truth Used

• Clinical Diagnosis: For clinical sensitivity and specificity studies, samples were linked to known diagnoses such as "Graves' Disease" and "Autoimmune Thyroiditis." The basis for these diagnoses (e.g., pathology, clinical outcomes, or expert opinion) is not detailed beyond being "clinically defined."
• Predicate Device: For method comparison, the reference standard was the legally marketed predicate device (VarelisA TG Antibodies and VarelisA TPO Antibodies).
• External Program Targets: For reference sera, the ground truth was the targets set by CAP (College of American Pathologists) and UK-NEQAS (United Kingdom National External Quality Assessment Service). These targets are often established by peer consensus or by the program providers.

8. The Sample Size for the Training Set

The document describes studies for validation of performance characteristics but does not explicitly mention a "training set" in the context of machine learning or AI development. Since these are immunoassays, they are based on biochemical reactions and calibration rather than a machine learning model that requires training data. The calibration process uses specific calibrator materials.

9. How the Ground Truth for the Training Set Was Established

As this is an immunoassay and not an AI/ML device, the concept of a "training set" with established ground truth doesn't apply in the same way. The device is calibrated using:

• EliA IgG Calibrator Strips: Human IgG at defined concentrations (0, 4, 10, 20, 100, 600 µq/L). These calibrators are traceable to the International Reference Preparation (IRP) 67/86 of Human Serum Immunoglobulins A, G and M from WHO. New batches are compared to a secondary standard or the IRP directly to ensure correct concentration. This traceability constitutes the "ground truth" for calibration.
• EliA IgG Curve Control Strips: Human IgG (20 µg/L) for monitoring calibration curve performance.

The "ground truth" for the calibrators is therefore established through established international reference standards and their traceability.

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EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 100.

EliA Scl-70s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA Scl-70s uses the EliA IgG method on the instrument Phadia 250.

The Phadia EliA immunodiagnostic system is automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages except the positive and negative controls are required to carry out an EliA Scl-70° test.

The acceptance criteria and study detailed in the provided document pertain to the EliA™ Scl-70S Immunoassay, an in vitro semi-quantitative test for IgG antibodies directed to Scl-70.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the clinical performance (sensitivity and specificity). However, it reports the performance of the EliA Scl-70S based on its clinical study. For analytical performance, the acceptance criteria are implied by the reported results meeting generally accepted ranges for such assays.

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