Search Results

ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instruments Phadia 1000, Phadia 2500 and Phadia 5000.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 instrument systems, and associated software, processes all steps of the assay and calculates results automatically after the assay is completed. Analytical and clinical validation of these components were performed on the representative instrument Phadia 250 and Phadia 1000.

Here's a breakdown of the acceptance criteria and study details for the ImmunoCAP Allergen Components, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a single summary table, but rather presents the results of studies supporting the device's performance. The implied acceptance criteria for most analytical studies would be that the results achieved demonstrate suitable performance for the intended use (e.g., low imprecision, good linearity, sufficient detection limits, absence of significant interference, and adequate stability).

For the purpose of this summary, I'll extract the key performance metrics and the reported results from the provided text.

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

• Precision/Reproducibility:
  • Within-laboratory: 5 or 6 positive samples tested in 4 replicates per day for 20 days (total 80 replicates per sample), except for one sample with 3 replicates for 11 runs over 20 days (33 replicates).
  • Lot-to-lot: 4 or 5 positive samples and 1 negative sample. Each lot (3 lots total) tested with 12 replicates per sample in one run.
  • Provenance: Not explicitly stated, but clinical and non-clinical samples are mentioned in other studies suggesting human samples.
• Linearity: 3 or 4 positive samples, each diluted to generate at least six 2-fold consecutive dilutions. Samples tested with a minimum of 4 replicates in one run.
  • Provenance: Not explicitly stated, but clinical/patient samples are implied.
• Detection Limit: 5 blank samples (for LoB) and 5 low positive samples (for LoD). Blank samples determined in 3 runs with 5 replicates per run. Low positive samples measured in 15 replicates.
  • Provenance: Not stated.
• Analytical Specificity (Inhibition Studies): One positive sample for each ImmunoCAP Allergen component.
  • Provenance: Not stated, implied human.
• Interference (Endogenous Substance): Three samples (two positive and one negative) for each ImmunoCAP Allergen component.
  • Provenance: Not stated, implied human.
• Stability: Three lots of each ImmunoCAP Allergen component. The accelerated stability study for rSes i 1 (f449) used two positive and one negative sample across three lots.
  • Provenance: Not stated.
• Method Comparison Study (vs. Predicate):
  • f433, rTri a 14: 33 positive clinical samples, 10 positive non-clinical samples, 100 negative samples. Total = 143.
  • f416, rTri a 19: 34 positive clinical samples, 14 positive non-clinical samples, 100 negative samples. Total = 148.
  • f449, rSes i 1: 32 positive clinical samples, 30 positive non-clinical samples, 100 negative samples. Total = 162.
  • Provenance: Samples from individuals with clinical history of allergy-like symptoms, sensitized individuals without documented clinical history, and healthy non-atopic donors. The location or retrospective/prospective nature is not specified, but it implies a mix of historical and presumably current clinical samples.
• Clinical Sensitivity and Specificity:
  • f433, rTri a 14: 133 atopic (clinical history of allergy-like symptoms upon exposure to wheat, physician-diagnosed) and 100 non-atopic (healthy, no reported clinical reaction to allergen) samples. Total = 233.
  • f416, rTri a 19: 129 atopic and 100 non-atopic samples. Total = 229.
  • f449, rSes i 1: 35 atopic and 100 non-atopic samples. Total = 135.
  • Provenance: "Selected samples from individuals with a clinical history of allergy-like symptoms upon exposure to wheat/sesame, as diagnosed by a physician" and "samples from healthy subjects with no reported clinical reaction." Location and retrospective/prospective nature not explicitly stated.

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

• For the Clinical Sensitivity and Specificity studies, the ground truth for "atopic" cases was established by "clinical diagnosis of allergy" by a "physician." The specific number or qualifications of these physicians are not detailed in the document. For "non-atopic" cases, it relied on "no reported clinical reaction to the allergen."

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for establishing the clinical diagnosis (ground truth) in the clinical studies. The mention of "diagnosed by a physician" suggests individual physician diagnoses were used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that measures allergen-specific IgE levels, not an imaging device or AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This device is a standalone diagnostic test in the sense that the assay itself provides quantitative results for specific IgE antibodies. The performance characteristics described (precision, linearity, detection limit, analytical specificity, interference, stability, method comparison, and clinical sensitivity/specificity) are all "algorithm only" or device-only performance measures. The "human-in-the-loop" aspect comes in the interpretation of these quantitative results by a clinician in conjunction with other clinical findings, as stated in the Indications for Use. The clinical studies evaluate how well the device's output correlates with a clinical diagnosis, not how well humans perform with or without the device.

7. The Type of Ground Truth Used

• Clinical Diagnosis (by a physician) / Reported Clinical Reaction: For the clinical sensitivity and specificity studies, the ground truth was based on a "clinical diagnosis of allergy" by a physician for atopic individuals and "no reported clinical reaction" for non-atopic individuals.
• Absence of IgE Antibodies / Healthy Non-atopic Donors: For the method comparison study, "healthy, non-atopic donors" and "undetectable levels of specific IgE antibodies" (

Ask a specific question about this device

EliA Ro52 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro52 in human serum as an aid in the diagnosis of Sjögren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM) in conjunction with other laboratory and clinical findings. EliA Ro52 uses the EliA IgG method.

EliA Ro60 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro60 in human serum as an aid in the diagnosis of Sjögren's syndrome (SS) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Ro60 uses the EliA IgG method.

The EliA Ro52 and EliA Ro60 Immunoassays are semi-quantitative solid-phase fluoroenzyme immunoassays, for the determination of autoantibodies against SS-A/Ro 52 kDa and 60 kDa proteins. The EliA Ro52 and EliA Ro60 test System is a fully integrated and automated system composed of assay-specific reagents, EliA method-specific reagents, and general reagents.

The provided document describes the EliA Ro52 and EliA Ro60 Immunoassays, which are intended for the semi-quantitative measurement of IgG antibodies directed to Ro52 and Ro60 in human serum, respectively. These devices aid in the diagnosis of specific autoimmune diseases. The document includes detailed analytical and clinical performance data to support the substantial equivalence claim.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a tabulated format. Instead, it presents various analytical and clinical performance metrics, implying that these metrics, when compared to the predicate device and established clinical utility, are deemed acceptable for the device's intended use. Based on the provided performance data, the implicit acceptance criteria would likely be related to aspects like precision, linearity, detection limits, specificity (interference), and clinical sensitivity/specificity.

Below is a table summarizing key performance indicators reported in the document:

Table 1: Key Performance Metrics for EliA Ro52 and EliA Ro60

The acceptance of these performance metrics is implicitly based on comparison with the predicate devices (QUANTA Flash Ro52 and QUANTA Flash Ro60) and the established clinical utility in diagnosing the mentioned autoimmune diseases. The FDA's substantial equivalence determination (K210902) confirms that the submitted data supports the claim that the new devices perform comparably to the predicate devices.

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

The document describes several test sets for different performance characteristics:

• Precision/Reproducibility:
  • Phadia 250: 5 samples, each with 252 replicate determinations (across 3 instruments, 7 days, 21 runs).
  • Within-lab Imprecision: Samples in 80 replicates on 1 instrument over 20 days (40 runs).
  • Phadia 2500 and Phadia 5000 series (E-module): 5 samples, each with 84 replicates (across 3 instruments, 7 days, 21 runs).
• Linearity/Assay Reportable Range: 3 patient serum samples serially diluted in at least 9 dilution steps, tested in quadruplicates.
• Detection Limit: 4 blank and 4 low-level samples, tested in 5-fold determination, across 2 different reagent sets (totaling 120 combined observations for blank and low-level per instrument type).
• Analytical Specificity (Interference): 3 serum samples (negative, equivocal, high positive), spiked with interfering substances, tested in triplicates.
• Method Comparison with Predicate Device:
  • EliA Ro52: 208 patient serum samples (only 181 used in agreement calculations due to samples outside measuring range).
  • EliA Ro60: 208 patient serum samples (only 104 used in agreement calculations due to samples outside measuring range).
• Clinical Sensitivity and Specificity:
  • EliA Ro52: 755 clinically and ethnically defined serum samples. These include:
    • Diagnostic group: SLE (n=120), Sjögren's syndrome (n=60), IIM (n=94), SSc (n=91) - total 365.
    • Disease control group: 390 samples (various autoimmune and infectious diseases).
  • EliA Ro60: 713 clinically and ethnically defined serum samples. These include:
    • Diagnostic group: SLE (n=120), Sjögren's syndrome (n=60) - total 180.
    • Disease control group: 533 samples (various autoimmune and infectious diseases, excluding SSc).

Data Provenance:
The document states that the clinical samples used for sensitivity and specificity determination were from "clinically and ethnically defined serum samples, including those of US origin." This indicates a mix of retrospective (clinically defined, likely banked samples) and potentially prospective (if US origin implies some form of fresh collection for the study) data. It is not explicitly stated whether it was purely retrospective or involved prospective collections, but the description "clinically and ethnically defined serum samples" strongly suggests retrospective use of samples with established diagnoses.

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

The document does not provide information on the number of experts used to establish the ground truth for the test sets (e.g., for diagnoses of SLE, SS, IIM, SSc). It only states that samples were "clinically and ethnically defined." This typically implies that patient diagnoses were established through standard clinical practice by medical professionals, but the specifics of these experts' qualifications or the consensus process are not detailed in this submission summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for establishing the ground truth for the test set. It refers to diagnoses as "clinically defined," which generally suggests diagnosis was made by treating physicians following clinical guidelines, but no adjudication process like 2+1 or 3+1 by independent experts is mentioned for the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes an in vitro diagnostic (IVD) device, specifically an immunoassay for measuring antibody levels. MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation is involved and needs to be compared with and/or augmented by AI. This device is an automated laboratory test, and its performance is evaluated directly through analytical measurements and comparison to a predicate device, as well as clinical sensitivity and specificity against established clinical diagnoses.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is a standalone device. The EliA Ro52 and EliA Ro60 Immunoassays are "automated semi-quantitative solid phase fluoroenzymeimmunoassays" run on "Phadia 250 instrument and the Phadia 5000 instrument series (E-modules)." The results are automatically converted to EliA U/mL. The performance characteristics described (precision, linearity, detection limit, analytical specificity, clinical sensitivity, specificity) are all based on the output of the automated instrument and reagents, independent of human interpretation during the actual test process itself. The interpretation of results (negative, equivocal, positive) is based on defined cut-off values.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical sensitivity and specificity studies, the ground truth was clinical diagnosis. The samples were "clinically and ethnically defined serum samples" with established diagnoses of various autoimmune diseases (SLE, SS, IIM, SSc) and control conditions. This implies that the diagnosis was based on the standard clinical criteria and medical records established by healthcare professionals, rather than a separate expert consensus panel or specific pathology results for the study.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI models, as this is an immunoassay and not an AI/ML-based device.

However, if "training set" is generally interpreted as samples used for assay development, optimization, or establishing parameters like cut-offs, the relevant information is:

• Cut-off definition: A cohort of 69 healthy blood donors, 19 SLE patients, and 9 Sjögren's syndrome (SS) patients for EliA Ro52, and 70 healthy blood donors, 22 SLE patients, and 6 Sjögren's syndrome patients for EliA Ro60, were used to define the cut-off values. This can be considered the 'development' or 'calibration' set for determining the interpretive thresholds.

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

As noted above, this device does not utilize a machine learning "training set" in the conventional sense. For the samples used to establish the cut-off values (which could be considered analogous to determining a 'decision boundary' in an ML context), the ground truth was established based on the clinical diagnoses of the patient samples (healthy blood donors, SLE patients, Sjögren's syndrome patients). The document states that the initial cut-off for EliA Ro52, set using SLE and SS patients, was later verified with additional IIM and SSc patient sera. This indicates clinical diagnosis as the gold standard.

Ask a specific question about this device

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

EliA Rib-P is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against Rib-P. The EliA Rib-P test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.

Assav-Specific Reagents include:

• EliA Rib-P Wells: coated with human recombinant ribosomal P-proteins P0, P1 . and P2 - 2 carriers (12 wells each), ready to use;
• . EliA ANA 3 Positive Control 250 or 2500/5000: Human monoclonal antibodies in Tris buffer containing IgG antibodies to Ro52, Rib-P and RNA Pol III – 6 single use vials, 0.3 mL each, ready to use;
• . EliA IgG/IgM/IgA Negative Control 250 or 2500/5000: Human blood preparation 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 Method-Specific Reagents include:

• 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;
• I EliA IqG Conjuqate 50 or 200: ß-Galactosidase labeled anti-lgG (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 IgG Calibrator Strips: Human IqG (0, 4, 10, 20, 100, 600 uq/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 ug/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 Calibrator Well: coated with mouse monoclonal antibodies 4 carriers . (12 wells each), ready to use;

General Reagents include:

• Development Solution: 0.01% 4-Methylumbelliferyl-β-D-galactoside, 110, 6x >170, or 6x >1165 determinations;
• I Stop Solution: 4% Sodium Carbonate - 6 bottles (65 mL, 119 mL, or 2800 mL each), sufficient for 6x >292, 6x >560, or 6x >13100 determinations;
• 트 Washing Solution Additive: detergent, preservative

The provided document is a 510(k) Summary for the EliA Rib-P device, an in vitro semi-quantitative immunoassay for detecting IgG antibodies directed to Rib-P as an aid in diagnosing Systemic Lupus Erythematosus (SLE). This document does not describe a study involving an AI-enabled device or human-in-the-loop performance. Instead, it focuses on the analytical and clinical performance of a standalone laboratory diagnostic device and its substantial equivalence to a predicate device.

However, I can extract and structure the information related to acceptance criteria and the performance study of this specific diagnostic device in the format requested, even without AI-specific parameters.

Acceptance Criteria and Device Performance Study for EliA Rib-P

The EliA Rib-P device is an automated semi-quantitative solid phase fluoroenzymeimmunoassay for the measurement of IgG antibodies directed to Rib-P in human serum. This summary outlines the performance characteristics tested to demonstrate its substantial equivalence to a legally marketed predicate device, the Quanta Lite Ribosome P ELISA.

1. Table of Acceptance Criteria and the Reported Device Performance

• Range of Total Imprecision %CV across 5 samples: 4.0% - 13.3%
• Within-lab Imprecision %CV across 4 samples: 3.5% - 13.8%
  Phadia 2500/5000:
• Range of Total Imprecision %CV across 5 samples: 5.7% - 18.4% (one sample had high CV, 18.4%) |
  | Linearity/Reportable Range| Coefficient of determination (R²) close to 1.00, and slopes close to 1.00, across the measuring range. CLSI EP6-A guidelines followed. | Phadia 250:
• R² values: 1.00 for all three dilution ranges.
• Slopes: 0.95, 1.00, 1.00.
  Phadia 2500E:
• R² values: 0.99, 1.00, 0.99 for the three dilution ranges.
• Slopes: 1.03, 1.00, 1.02.
  "Linearity was shown for the entire measuring range." |
  | Detection Limit | LoB, LoD, and LoQ to be established according to CLSI EP17-A2 guidelines (false positives and false negatives 10 EliA U/mL |
  | Comparison Studies | | |
  | Method Comparison (vs. Predicate Device) | High Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Total Agreement with the predicate device. CLSI EP09c-ED3 followed. | EliA Rib-P (equivocal considered negative):
• PPA: 94.7% (95% CI: 82.3% - 99.4%)
• NPA: 98.6% (95% CI: 96.4% - 99.6%)
• Total Agreement: 98.1% (95% CI: 96.0% - 99.3%)
  EliA Rib-P (equivocal considered positive):
• PPA: 100% (95% CI: 90.7% - 100%)
• NPA: 88.1% (95% CI: 83.7% - 91.6%)
• Total Agreement: 89.5% (95% CI: 85.6% - 92.6%) |
  | Instrument Comparison | Strong correlation and agreement between different Phadia instrument series. | Regression analysis showed a slope of 0.94 (95% CI: 0.93 - 0.98) and an intercept of -0.76 (95% CI: -1.20 - -0.48) between Phadia 250 and Phadia 2500E. |
  | Clinical Studies | | |
  | Clinical Sensitivity and Specificity | Acceptable sensitivity for SLE and high specificity against other autoimmune and infectious diseases. | EliA Rib-P (equivocal considered positive):
• Sensitivity (for SLE): 34.9% (95% CI: 27.2% - 43.3%)
• Specificity (against disease controls): 99.3% (95% CI: 97.9% - 99.9%)
  EliA Rib-P (equivocal considered negative):
• Sensitivity (for SLE): 28.1% (95% CI: 21.0% - 36.1%)
• Specificity (against disease controls): 99.8% (95% CI: 98.7% - 100%) |

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

• Precision/Reproducibility:
  • Phadia 250: 5 samples, tested in 252 replicates each across 3 lots and 3 instruments over 7 days.
  • Within-Lab Imprecision: 4 samples, tested in 80 replicates each on 1 instrument over 20 days.
  • Phadia 2500/5000 (E-module): 5 samples, tested in 84 replicates each on 3 instruments over 7 days.
  • Provenance: Not explicitly stated, typically laboratory-prepared controls or banked human serum samples.
• Linearity/Assay Reportable Range: 3 serum samples (diluted). Provenance not explicitly stated.
• Detection Limit: 4 blank and 4 low-level samples (depleted IgG sera and prepared low-level samples) tested in 5-fold determination across 3 runs on Phadia 250 and Phadia 2500E.
• Analytical Specificity (Interference): 3 serum samples (one negative, one equivocal, one high positive) spiked with interfering substances. Provenance not explicitly stated.
• Assay Cut-Off: A cohort of 70 apparently healthy blood donors and 30 samples from SLE patients. Provenance not explicitly stated.
• Method Comparison with Predicate Device: 323 patient samples. Provenance not explicitly stated, but implies diverse clinical samples covering the measuring range.
• Instrument Comparison: 47 positive, 10 equivocal, and 28 negative samples. Provenance not explicitly stated.
• Clinical Sensitivity and Specificity: 560 clinically defined serum samples from various diagnostic groups (146 SLE, 414 disease controls). Provenance not explicitly stated, but these are patient samples with confirmed diagnoses.
• Expected Values/Reference Range: 638 apparently healthy subjects, equally distributed by age and gender from Caucasian, African American, Hispanic, and Asian populations obtained from a blood bank.

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

The document does not mention the use of experts to establish ground truth for the analytical performance characteristics. For clinical studies, the "ground truth" for patient samples was based on "clinically defined serum samples with a diagnosis" (e.g., systemic lupus erythematosus, Celiac disease, etc.). This typically implies diagnosis by medical professionals (e.g., rheumatologists, gastroenterologists, etc.) based on established diagnostic criteria, but the number and specific qualifications of these experts are not explicitly stated in this summary.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

No explicit adjudication method is mentioned. The ground truth for clinical samples appears to be based on pre-existing clinical diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

This section is not applicable as the device is a standalone in vitro diagnostic immunoassay, not an AI-enabled device or an assist device for human readers. No MRMC study was conducted.

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

This device is a standalone algorithm/device in the sense that it performs automated semi-quantitative measurement of antibodies without real-time human interpretation impacting the measurement result. The assay directly measures the amount of antibody via fluorescence. The interpretation of results (negative, equivocal, positive) is based on predefined cut-offs.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

• Analytical ground truth: Based on reference materials, spiked samples, and dilution series with known concentrations or characteristics.
• Clinical ground truth: "Clinically defined serum samples with a diagnosis" (e.g., SLE patients, various disease controls). This implies established clinical diagnoses, likely based on standard diagnostic criteria, which could involve expert clinical assessment, pathology, and other laboratory findings.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. For a traditional immunoassay, method development and optimization would involve various experiments and sample sets, but these are not explicitly termed "training sets" here. The "Assay Cut-Off" study used 70 healthy blood donors and 30 SLE patients to define the cut-off, which could be considered a form of "training" for the interpretive criteria.

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

As noted above, a formal "training set" in the AI sense is not described. For the cut-off determination, the ground truth was established by using "apparently healthy blood donors" and "samples from SLE patients," indicating that these samples had known clinical statuses (healthy or diagnosed with SLE).

Ask a specific question about this device

EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in conjunction with other laboratory and clinical findings. EliA RNA Pol III uses the EliA IgG method.

EliA RNA Pol III is a semi-quantitative solid-phase fluoroenzymeimmunoassay, for the determination of autoantibodies against RNA polymerase III. The EliA RNA Pol III test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.

Here's a breakdown of the acceptance criteria and study information for the EliA RNA Pol III device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Test Set (Method Comparison with Predicate Device):
  • Sample Size: 193 patient serum samples.
  • Data Provenance: Not explicitly stated, but includes 126 samples with a diagnosis of SSc. The context suggests these are clinical samples.
• Test Set (Clinical Sensitivity and Specificity):
  • Sample Size: 596 clinically defined serum samples.
  • Data Provenance: Clinically defined samples from patients with various diagnoses, including Systemic Sclerosis (diffuse and limited forms), and various control diseases/conditions (e.g., Celiac disease, Crohn's disease, SLE, RA, bacterial/viral infections). The text does not specify country of origin or if prospective/retrospective; however, "clinically defined serum samples" typically implies retrospective collection with known diagnoses.
• Test Set (Assay Cut-Off):
  • Sample Size: 70 apparently healthy blood donor samples and 17 target disease (Systemic Sclerosis, diffuse) samples.
  • Data Provenance: "apparently healthy blood donor samples" and "target disease samples" (Systemic Sclerosis, diffuse). The text explicitly mentions "sera from Caucasian, African American, Hispanic and Asian population obtained from a blood bank" for the frequency distribution, which likely overlaps with the "apparently healthy blood donor samples" used for cut-off establishment.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The wording "clinically defined serum samples with a diagnosis" implies that the diagnoses used as ground truth were established clinically by medical professionals, but their specific roles, number, or years of experience are not detailed.

4. Adjudication Method (Test Set):

• Adjudication Method: Not specified. The diagnostic labels for the clinical samples are presented as established fact without mention of an adjudication process.

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

• Was an MRMC study done? No. This device is an in-vitro diagnostic (IVD) assay designed for automated measurement of antibodies, not for interpretation by human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance:

• Was a standalone study done? Yes. The entire performance evaluation, including analytical performance, method comparison, and clinical sensitivity/specificity, evaluates the performance of the EliA RNA Pol III assay itself (the "algorithm only" in this context, as it's an automated system) without human interpretation as part of the primary measurement. The results are generated directly by the instrument.

7. Type of Ground Truth Used:

• For Method Comparison: The ground truth was the results from the predicate device, QUANTA LITE RNA POL III ELISA.
• For Clinical Sensitivity and Specificity: The ground truth was clinical diagnosis ("clinically defined serum samples with a diagnosis from patients with systemic sclerosis, diffuse," etc.).
• For Assay Cut-Off: The ground truth was based on apparently healthy blood donors and clinically diagnosed Systemic Sclerosis, diffuse patients.

8. Sample Size for the Training Set:

• Training Set (Assay Cut-Off establishment): This involved 70 apparently healthy blood donor samples and 17 target disease (Systemic Sclerosis, diffuse) samples. While not explicitly called a "training set," these samples were used to "define the cut-off," which is a form of model training/optimization for classification.
• Other "training" data: The document mentions that "New batches of IgG calibrators are compared to a secondary standard (standardized with the IRP) or the IRP directly and adjusted accordingly to meet the correct concentration." This implies a continuous process of calibration and standardization, where previous data/standards (IRP) could be considered a form of "training" for the calibrators. However, a distinct, large-scale training set for an AI/algorithm in the conventional sense is not detailed as this is a chemical assay.

9. How the Ground Truth for the Training Set was Established:

• For Assay Cut-Off establishment: The ground truth for the 70 apparently healthy blood donors means they were confirmed healthy (presumably through standard screening). For the 17 Systemic Sclerosis (diffuse) samples, the ground truth was their clinical diagnosis.
• For Calibrators: The ground truth for calibrators is established through their traceability to the International Reference Preparation (IRP) 67/86 of Human Serum Immunoglobulins A, G and M from WHO.

Ask a specific question about this device

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.

Ask a specific question about this device

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine, is intended for in vitro diagnostic use, in human serum or EDTA plasma, as an aid in the diagnosis of IgE mediated mammalian (red) meat hypersensitivity, due to alpha-Gal sensitization, and to be used in conjunction with other clinical findings. This test is not to be the sole criterion for diagnosing allergy to alpha-Gal. It is a quantitative test to be used in clinical laboratories. ImmunoCAP Allergen 0215, alpha-Gal is to be used with the ImmunoCAP Specific IgE assay on the instrument Phadia™ 250.

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine, is a component of, and is designed to be used with, the ImmunoCAP Specific IgE assay, previously cleared under K051218. The test has the same overall design as all other ImmunoCAP Allergen components and uses identical assay and system specific reagents, instruments and software.

This document describes the performance characteristics and acceptance criteria for the ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine test, which is intended to aid in the diagnosis of IgE mediated mammalian (red) meat hypersensitivity.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes both analytical and clinical performance studies, but directly states acceptance criteria only for analytical performance implicitly through the successful completion of the studies. For clinical performance, it discusses the study design and patient numbers, from which performance can be inferred.

Analytical Performance Characteristics:
The document states that analytical performance characteristics were established by studies of:

• Precision
• Lot-to-Lot Reproducibility
• Linearity
• Limit of Quantitation
• Sample Matrix Equivalency
• Interference
• Inhibition
• Stability

While specific numerical acceptance criteria for each of these analytical characteristics are not explicitly listed in the provided text, the overall conclusion is that the device's analytical performance was verified and supports its substantial equivalence. The document concludes: "Analytical performance characteristics for the new ImmunoCAP Allergen Components were established by studies of Precision, Lot-to-Lot Reproducibility, Linearity, Limit of Quantitation, Sample Matrix equivalency, Interference, Inhibition and Stability." This implies that the device met the pre-defined acceptance criteria for these analytical aspects.

Clinical Performance Characteristics:
For clinical performance, a retrospective study was conducted. The document does not explicitly present a table of acceptance criteria (e.g., minimum sensitivity, specificity) against which the device's performance was measured for clinical use. Instead, it describes the study design, and the implied acceptance is that the device demonstrated sufficient performance to be considered an "aid in the diagnosis."

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

• Test Set Sample Size: The clinical performance was evaluated using samples from 200 subjects with a case history of mammalian meat hypersensitivity (cases) and 110 control subjects.
• Data Provenance: The study was a retrospective study. The country of origin of the data is not specified in the provided text.

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

The document does not specify the number of experts used to establish the ground truth for the test set, nor does it detail their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions that the 200 subjects had a "case history of mammalian meat hypersensitivity," implying that their status was established through clinical diagnosis, likely by medical professionals.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set.

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

No MRMC comparative effectiveness study was reported in which human readers' improvement with AI vs. without AI assistance was assessed. This device is an in-vitro diagnostic assay, not an AI-assisted imaging device, so such a study would not be applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

This device is an in-vitro diagnostic test kit that provides quantitative measurements of IgE antibodies. Its performance, as described, is inherently "standalone" in the sense that the test itself generates a result without direct human interpretation influencing the measurement, though human interpretation is required for the final diagnostic aid. The "performance characteristics" detailed refer to the analytical and clinical performance of the assay itself, which is analogous to a standalone performance evaluation in the context of an IVD.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on a "case history of mammalian meat hypersensitivity" for the 200 subjects and "control subjects" for the 110 individuals. This suggests that the ground truth was established by clinical diagnosis and patient history, rather than a specific expert consensus on images, pathology, or outcomes data from a prospective study directly.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. This is typical for an IVD assay, where performance is established through validation studies rather than machine learning model training. The development process for such an assay would involve internal development and optimization, but not typically in the sense of a machine learning training set with a distinct ground truth establishment process as described for AI models.

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

Since no distinct "training set" is mentioned in the context of this device's validation, the method for establishing its ground truth is not applicable. The development of an IVD assay involves extensive R&D, but the concept of "ground truth for a training set" usually applies to machine learning algorithms.

Ask a specific question about this device

EliA SymphonyS is intended for the in vitro, qualitative measurement of antibodies in human serum and plasma (Li-heparin, EDTA). EliA SymphonyS is based on human recombinant U1RNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SSB/La, Centromere B, Scl-70, Jo-1 proteins and a synthetic SmD3 peptide as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderna and polymyositis, in conjunction with other laboratory and clinical findings. EliA SymphonyS uses the EliA IgG method on the instrument Phadia 250.

EliA SymphonyS is intended for the in vitro, qualitative measurement of antibodies in human serum and plasma (Li-heparin, EDTA). EliA SymphonyS is based on human recombinant U1RNP (RNP 70, A, C), SS-A/Ro (60 kDa, 52 kDa), SSB/La, Centromere B, Scl-70, Jo-1 proteins and a synthetic SmD3 peptide as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis, in conjunction with other laboratory and clinical findings. EliA SymphonyS uses the EliA IgG method on the instrument Phadia 2500/5000.

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 Symphony® Wells are coated with human recombinant U1RNP (RNP70, A. -C). SS-A/Ro (60 kDa. 52 kDa). SS-B/La. Centromere B. Scl-70. Jo-1 proteins and synthetic SmD3 peptide - 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 ANA Positive Control 250 or 2500/5000: Human serum containing lgG antibodies to dsDNA, RNP, Sm, Ro. La. Scl-70. CENP and Jo-1 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 IgG (0, 4, 10, 20, 100, 600 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 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 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. Apart from the EliA ANA Positive Control 250 or 2500/5000 and the EliA IqG/IqM/IgA Neqative Control 250 or 2500/5000, all packages listed above are required to carry out an EliA SymphonyS Test.

Here's a breakdown of the acceptance criteria and study information for the EliA SymphonyS Immunoassay, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

2. Sample Size and Data Provenance (Test Set)

• Precision Study (Phadia 250): 5 samples, 252 replicates per sample (totaling 1260 determinations). Data provenance not explicitly stated, but clinical samples are generally used for such studies.
• Precision Study (Phadia 2500/5000): 7 samples, 84 replicates per sample (totaling 588 determinations). Data provenance not explicitly stated.
• Interference Study: 3 serum samples (negative, cut-off, high positive), analyzed in triplicates, repeated twice. Spiked with specific interfering substances. Data provenance not explicitly stated.
• Cut-off Study: 70 apparently healthy blood donor samples from Caucasian individuals (equally distributed by sex and age). 30 ANA positive samples with known reactivities. Data provenance not explicitly stated.
• Method Comparison Study: 633 serum samples from patients with various diagnoses (Mixed Connective Tissue Disease, Poly-/Dermatomyositis, Systemic Sclerosis, SLE, Sjögren's Syndrome, Bacterial Infection, HIV Infection, HCV Infection, HBV Infection, Rheumatoid Arthritis, Cancer). Data provenance not explicitly stated (likely retrospective clinical samples from diverse sources).
• Matrix Comparison Study: 62 patients, serum, lithium heparin plasma, and EDTA plasma collected from the same patients. Data provenance not explicitly stated.
• Instrument Comparison Study: 110 samples (81 positive, 10 equivocal, 19 negative). Data provenance not explicitly stated.
• Clinical Sensitivity and Specificity Study: 444 clinically defined samples with a diagnosis from patients with various autoimmune diseases and control conditions (Mixed Connective Tissue Disease, Poly-/Dermatomyositis, Systemic Sclerosis, SLE, SLE/Lupus nephritis, Sjögren's Syndrome, Bacterial Infection, Viral Infection, Rheumatoid Arthritis, Celiac Disease, Crohn's Disease, Ulcerative Colitis, Graves' Disease, Hashimoto's Disease, primary Antiphospholipid Syndrome, PBC, Autoimmune hepatitis, Granulomatosis with Polyangiitis). Data provenance not explicitly stated (likely retrospective clinical samples from diverse sources).
• Expected Values/Reference Range Study: 558 apparently healthy subjects (Caucasian, African American, Hispanic and Asian population) obtained from a blood bank. This suggests diverse geographic and demographic provenance for the "normal" population.

Most of the studies likely used retrospective clinical samples, given the disease-specific grouping. No specific country of origin is mentioned for individual studies, but the applicant is Phadia AB from Sweden, and the 510(k) contact is in the USA, implying potential multi-site studies or data collection.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.

• For the "clinically defined samples" in the clinical sensitivity/specificity study, the "diagnosis from patients" would be considered the ground truth, presumably established by treating physicians based on clinical findings and other laboratory tests, but not by a specific panel of experts for the purpose of this device's validation.
• Reference sera (CDC and AMLI) have "target" values, which are established by their respective institutions (Centers for Disease Control and Prevention, and Association of Medical Laboratory Immunologists) and represent a consensus or assigned value, but not necessarily a specific "number of experts" for this study.

4. Adjudication Method for the Test Set

The document does not mention any explicit adjudication method (e.g., 2+1, 3+1) for establishing the ground truth for the test set. Clinical diagnoses are typically made by single treating physicians, and reference materials have predefined target values.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic immunoassay, which does not involve human readers interpreting results in the same way an imaging AI might. Its performance is measured directly through analytical and clinical studies against predicate devices or known clinical statuses.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the device performance described is standalone (algorithm only). The EliA SymphonyS Immunoassay is an automated system that measures antibody levels and provides a qualitative result (negative, equivocal, positive) based on predefined cut-offs, without direct human-in-the-loop interpretation during the measurement process. The "aid in clinical diagnosis" part implies that clinicians interpret the results in conjunction with other findings, but the device itself operates in a standalone manner.

7. Type of Ground Truth Used

The types of ground truth used include:

• Clinical Diagnoses: For the clinical sensitivity/specificity study, the "diagnosis from patients with" various diseases (e.g., SLE, MCTD, Sjögren's syndrome) served as the ground truth. This is based on established clinical criteria for each disease.
• Reference Material Targets: For the evaluation of CDC and AMLI sera, the "Target" reactivity/results defined by these external institutions were used as ground truth.
• Expected Behavior: For precision, interference, carry-over, and cut-off studies, the ground truth is often the expected behavior of the assay (e.g., negative sample should be negative, spiked sample should show no interference, etc.) or statistically derived values from healthy populations.
• Predicate Device Results: For the method comparison study, the results from the legally marketed predicate device (EliA Symphony) served as a comparative ground truth to demonstrate substantial equivalence.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning. This is an immunoassay, which typically relies on established biochemical reactions, calibration curves, and empirically determined cut-offs rather than a machine learning model that requires a discrete training phase with labeled data. The calibration curve is established using calibrator strips (human IgG at known concentrations).

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

As noted above, there isn't a "training set" in the machine learning sense for this immunoassay.

• The calibration curve is established using EliA IgG Calibrator Strips, which contain human IgG at known concentrations (0, 4, 10, 20, 100, 600 µg/L). The "ground truth" for these calibrators is their precisely defined IgG concentrations, which are traceable to the International Reference Preparation (IRP) 67/86 of Human Serum Immunoglobulins A, G and M from WHO.
• The cut-off values (0.7 Ratio and 1.0 Ratio) were established by evaluating 70 apparently healthy blood donor samples and taking into account the 95th percentile, along with testing 30 ANA positive samples with known reactivities. This is a form of empirical ground truth setting based on biological distribution and known positive/negative samples.

Ask a specific question about this device

ImmunoCAP Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000 instrument systems, associated software, processes all steps of the assay and calculates results and a automatically after the assay is completed.

The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

The provided text describes a 510(k) submission for new ImmunoCAP Allergen Components (rCan f 4 Dog, rCan f 6 Dog, rFel d 7 Cat) to an existing ImmunoCAP Specific IgE assay system. While it mentions performance characteristics studies, it does not provide a specific table of acceptance criteria or reported device performance for these new components. It primarily focuses on the regulatory submission and overall claims of performance.

However, based on the provided text, I can infer and summarize what information is available and what is missing regarding acceptance criteria and the study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: The exact sample size for the "clinical positive samples" and "samples from healthy, nonatopic donors" is not provided.
• Data Provenance: The country of origin is not provided. The studies appear to be retrospective in nature, as they involve testing existing samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not provided in the document. For immunoassays, ground truth is typically established by the clinical status of the patient (e.g., diagnosed allergy, physician assessment, other valid allergy tests) rather than expert review of images.

4. Adjudication method for the test set

This information is not applicable as it pertains to expert review of diagnostic results, which is not described for this type of immunoassay. The ground truth would be based on the clinical diagnosis or reference methods.

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

• MRMC Study: This is not applicable. The device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

• Standalone Performance: The described studies (Precision, Reproducibility, Linearity, LOD, Stability, Clinical Comparison) all represent the standalone performance of the immunoassay system (device and instrument). There is no "human-in-the-loop" component for interpretation described beyond the overall clinical context for diagnosis.

7. The type of ground truth used

The ground truth for the clinical studies appears to be based on:

• Clinical Status: "clinical positive samples" imply patients with a diagnosed IgE-mediated allergic disorder related to the specific allergens.
• Absence of Allergy: "healthy, nonatopic donors" implies individuals without (or assumed to be without) IgE-mediated allergic disorders.
• Predicate Device Comparison: The new components were compared against an "extract based predicate device," which itself serves as a reference standard, implying its results are also part of the ground truth or a comparator for performance.

8. The sample size for the training set

This information is not applicable as the device is an immunoassay kit, not a machine learning or AI algorithm that requires a separate training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

Ask a specific question about this device

EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and EDTA-plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease in conjunction with other laboratory and clinical findings. EliA Celikey IgG uses the EliA IgG method on the instrument Phadia 2500/5000.

EliA GliadinDP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgA uses the EliA IgA method on the instrument Phadia 2500/5000.

EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA GliadinDP IgG uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K062583 (EliA Celikey IgG) and K093459 (EliA Gliadin® IgA and EliA Gliadin® IgG), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of: Test Wells (EliA Celikey IgG Wells, EliA GliadinDP IgA Wells, EliA GliadinDP IgG Wells), EliA Sample Diluent, EliA IgG reagents (EliA IgG Conjugate, EliA IgG Calibrator Strips, EliA IgG Curve Control Strips, EliA IgG Calibrator Well), and EliA IgA reagents (EliA IgA Conjugate, EliA IgA Calibrator Strips, EliA IgA Curve Control Strips, EliA IgA Calibrator Well). 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 Celikey IgG and EliA GliadinDP IgA and EliA GliadinDP IgG tests.

The provided document is a 510(k) Premarket Notification from the FDA, detailing the substantial equivalence determination for the Phadia AB EliA Immunoassays (Celikey IgG, GliadinDP IgA, GliadinDP IgG) for use on the Phadia 2500/5000 instrument. The document primarily focuses on demonstrating that the performance of these assays on the new instrument platform is substantially equivalent to their performance on a previously cleared instrument (Phadia 250).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a single table outlining "acceptance criteria" alongside "reported device performance" for the overall substantial equivalence determination. Instead, it details performance characteristics for various analytical aspects, and the acceptance criteria are implied by the ranges and thresholds specified for these studies. The primary "acceptance criteria" for the overall submission appear to be demonstrating equivalence to the predicate device and meeting specific statistical thresholds for precision and linearity.

However, based on the sections "M. Performance Characteristics (if/when applicable)" and "2. Comparison studies: - Instrument comparison C.", we can construct a table for the analytical performance and comparative study results:

Table: Acceptance Criteria (Implied) and Reported Device Performance

Ask a specific question about this device

EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma to aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K132631 (EliA SmDº on Phadia 250), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of:

• Test Wells: -EliA SmDP Wells are coated with a synthetic SmD3 peptide – 4 carriers (12 wells each), ready to use;
• 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 Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (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 SmDP tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device under review is the EliA SmDP Immunoassay on the Phadia 2500/5000 instrument. The study primarily evaluated the performance of this new instrument platform compared to a previously cleared device (EliA SmDP on Phadia 250, K132631). The acceptance criteria for the new device's performance are largely demonstrated through its equivalence to the predicate device.

• 24.8% at 2.2 EliA U/mL
• 8.8% at 10.0 EliA U/mL
• 6.5% at 146.6 EliA U/mL
• 8.8% at 408.1 EliA U/mL
  (within acceptable limits for immunoassays of this type) |
  | Linearity/Reportable Range | Implied to be linear across the measuring range, with slopes close to 1 and R2 values close to 1. | Linearity (Slope, 95% CI):
• 1.04 (0.95-1.12)
• 0.98 (0.94-1.02)
• 1.01 (0.97-1.05)
• 1.01 (0.99-1.02)
  R2 values: All 0.99 or 1.00
  Linear Range: 1.6 EliA U/mL (LoQ) to 480 EliA U/mL (upper limit)
  Reportable Range: 0.8 EliA U/mL (LoD) to 480 EliA U/mL (upper limit) |
  | Detection Limit (LoD) | Not explicitly stated as a specific numerical value. The study aimed to determine it. | LoD: 0.8 EliA U/mL (with

Ask a specific question about this device