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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay, based on the provided text:

Acceptance Criteria and Device Performance

The study evaluates the analytical performance and clinical performance of the device.

Analytical Performance Acceptance Criteria:

The key acceptance criteria for analytical performance are related to precision, linearity, and specificity. While explicit quantitative criteria were provided for precision, linearity had implied criteria based on excellent regression statistics, and specificity was demonstrated by successful inhibition.

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer/co-polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. Incubation Cycles: 2 × 30 minutes.

The provided document describes the Siemens Healthcare Diagnostics Inc. IMMULITE® 2000 3gAllergy™ Specific IgE Assay, which is an in vitro diagnostic device for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The document focuses on demonstrating the substantial equivalence of nine additional specific allergens for use with this existing assay.

Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for each performance characteristic (e.g., "Total CV must be

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. Incubation Cycles: 2 × 30 minutes.

The Siemens Healthcare Diagnostics Inc. IMMULITE® 2000 3gAllergy™ Specific IgE Assay is intended for the quantitative measurement of allergen-specific IgE in human serum, to aid in the clinical diagnosis of IgE-mediated allergic disorders.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for precision, linearity, or clinical performance in numerical terms for the new allergens to be cleared. However, the study results are presented to demonstrate acceptable analytical performance and comparability to clinical data.

Precision:
Precision was evaluated by calculating the intra-assay (Within-Run) and inter-assay (Total) percent coefficients of variation (%CV) for positive samples. The reported CVs are generally low, with within-run CVs mostly below 5% (with some exceptions like Positive #4 for Lime at 9.15%) and total CVs mostly below 6% (with some exceptions like Positive #4 for Lime at 11.47%). The document states that "acceptable analytical performance including precision" was demonstrated, implying these values met internal or regulatory expectations.

Linearity:
Linearity was assessed by comparing observed to expected data from 2-fold serial dilutions. The regression equations show slopes very close to 1 and intercepts close to 0, with 95% confidence intervals for both slope and intercept generally containing 1 and 0 respectively. This indicates good linearity across the tested range. The document states "acceptable analytical performance including linearity" was demonstrated.

Specificity (Inhibition Studies):
Specificity was confirmed through competitive inhibition testing. The acceptance criterion was explicitly stated as achieving a target % inhibition of 50% for the highest inhibitor concentration tested. The reported performance is that this target was met for all tested allergens.
Additional inhibition studies for cross-reactivity used a criterion of results being below 9.9% for specific allergens when tested with unrelated allergen extracts. The reported performance states that results were below 9.9% for Asparagus, Blueberry, Cauliflower, and Perch when tested with unrelated extracts, and for Apricot, Chili Pepper, Chub Mackerel, Ginger, Lime, and Whey.

Clinical Performance:
The document presents an agreement rate with clinical data. The acceptance criteria for clinical performance are implicitly defined by the reported lower and upper confidence intervals, which fall within generally accepted ranges for such diagnostic assays.

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. Incubation Cycles: 2 × 30 minutes.

The Siemens Healthcare Diagnostics Inc. IMMULITE® 2000 3gAllergy™ Specific IgE Assay is an in vitro diagnostic device intended for the quantitative measurement of allergen-specific IgE in human serum, to aid in the clinical diagnosis of IgE-mediated allergic disorders. The provided document focuses on the clearance of 27 additional specific allergens for use with this existing assay.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for precision, linearity, or specificity (inhibition). Instead, it presents the study results and concludes that they demonstrate "acceptable analytical performance." For clinical performance, it discusses general agreement with clinical data.

Therefore, the table below will summarize the reported performance metrics, implying that these results were deemed acceptable by the manufacturer and the FDA for substantial equivalence.

• Concentration-dependent inhibition.
• Target of 50% inhibition met at the highest inhibitor concentration tested (5 mg/mL, or the starting concentration for Haddock, Red Snapper, and Sole). |
  | Clinical Performance | Good agreement with clinical documentation of allergen sensitivity. | Sensitivity: 66.2% (Lower Conf 64%, Upper Conf 69%)
  Specificity: 98.9% (Lower Conf 99%, Upper Conf 99%)
  Overall Agreement: 89.1% (Lower Conf 88%, Upper Conf 90%) |

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

• Precision: Three positive samples and one negative sample were tested for each allergen. Each sample was assayed in two aliquots, two runs per day, on 20 different days, for three allergen lots. This setup aims to assess within-run and total precision across different batches and extended testing periods.
• Linearity: For each allergen, two samples were diluted in 2-fold serial dilutions to 5 levels. Each diluted and undiluted sample was tested.
• Specificity (Inhibition): A "single serum sample or pool of sera" was used for competitive inhibition testing for each allergen. A negative sample was used as a background control. Inhibition experiments involved 70uL of undiluted and minimally 4-5 levels of serially diluted inhibitor extract (5, 1, 0.2, 0.04, 0.008 mg/mL, and sometimes more dilute levels). Each sample mixture with inhibitor extract and controls was assayed with 1 lot of each allergen.
• Clinical Performance: 4,118 samples were tested: 1,238 from clinically positive individuals and 2,880 from clinically normal (non-atopic) individuals.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective for any of these studies. It can be inferred that these are prospective studies conducted by the manufacturer, Siemens Healthcare Diagnostics Inc., for regulatory submission.

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

• Precision, Linearity, Specificity: For these analytical performance studies, the "ground truth" is based on the inherent properties of the measurements and controls, rather than expert interpretation of a diagnostic outcome. The accuracy of the assay itself is being evaluated.
• Clinical Performance: For the clinical performance study, the "ground truth" (clinical data for IgE-mediated allergic disorders) was established based on "clinically diagnosed atopic and non-atopic individuals." The document does not specify the number or qualifications of the experts (e.g., allergists, physicians) who performed these clinical diagnoses.

4. Adjudication Method for the Test Set

• Precision, Linearity, Specificity: Not applicable. These are analytical studies where results are quantitative measurements against known standards or controls.
• Clinical Performance: The document states that the ground truth for clinical performance was based on "clinical data" to define individuals as "clinically diagnosed atopic and non-atopic individuals." There is no mention of an adjudication method (like 2+1, 3+1 consensus) explicitly detailed for the clinical diagnoses themselves. It implies that these were established clinical classifications prior to testing with the IMMULITE® 2000.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an imaging device or AI algorithm intended to assist human readers in interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

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

Yes, the studies evaluating the IMMULITE® 2000 3gAllergy™ Specific IgE Assay are fundamentally standalone. The device performs quantitative measurements of IgE levels in serum, and its performance (precision, linearity, specificity, and comparison to clinical diagnoses) is assessed based on these measurements. There is no "human-in-the-loop" component in the analytical operation of the assay or the interpretation of its quantitative output for the purpose of these performance studies. Clinicians then use these quantitative results, alongside other clinical information, for diagnosis.

7. Type of Ground Truth Used

• Precision, Linearity: Ground truth is based on known concentrations or expected values derived from serial dilutions.
• Specificity (Inhibition): Ground truth is based on the known presence and concentration of the inhibitor extract and the expected inhibition of the specific allergen reaction.
• Clinical Performance: The ground truth was "clinical data," referring to the diagnosis of "clinically diagnosed atopic and non-atopic individuals." This would typically involve a combination of patient history, physical examination, and potentially other diagnostic tests (e.g., skin prick tests, other lab results, patient symptoms, and outcomes). It is not solely pathology or "outcomes data" in a broader sense but relies on a clinical determination of allergy status.

8. Sample Size for the Training Set

The document describes performance studies for the device itself, not the development of an algorithm that would require a distinct "training set" in the context of machine learning or AI. Therefore, the concept of a training set for an AI algorithm is not applicable to this submission. The studies detailed are for validation of the assay performance.

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

As explained in point 8, the concept of a "training set" for an AI algorithm is not applicable to these studies for this in vitro diagnostic device.

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.

The provided text details the analytical and clinical performance of the IMMULITE® 2000 3gAllergy™ Specific IgE Assay for several new allergens.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for precision, linearity, or specificity. Instead, it presents the results of these studies and concludes that the performance is "acceptable" or "compares well" to clinical documentation.

However, based on the conclusions drawn and the type of data presented, implicit acceptance criteria can be inferred from the reported performance. The clinical performance section, in particular, provides quantifiable results that the device is deemed to meet.

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on analytical and clinical performance without explicitly stating numerical acceptance criteria prior to presenting the results. However, we can infer implied acceptance criteria from the reported performance, especially for linearity and specificity (inhibition). For clinical sensitivity and specificity, the provided confidence intervals suggest a critical range.

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

• Precision: For each of the seven allergens, three positive samples and one negative sample were tested. Each sample was assayed in two aliquots per day for 20 different days, totaling 40 measurements per sample.
• Linearity: For each allergen, two samples were diluted into 5 levels (undiluted + 4 dilutions). The table shows N=12 for each allergen, implying 2 samples * 5 dilutions + 2 undiluted samples.
• Specificity (Inhibition): A single serum sample or pool of sera was used for each allergen.
• Clinical Performance:
  • Total Patients: 1,157 individuals.
  • Clinical Data: 261 positive, 896 normal.
  • Data Provenance: The document does not explicitly state the country of origin. It samples were described as "samples from non-atopic individuals and samples from atopic patients with case histories of suspected clinical reactions." This indicates that the data is retrospective clinical data for the "clinical data" ground truth, likely collected from patients presenting with symptoms.

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

• The document does not specify the number of experts or their qualifications.
• For clinical performance, the ground truth is referred to as "clinical data" which includes "case histories of suspected clinical reactions to the specific allergen or allergy group" and "documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This suggests that the clinical diagnosis was established by medical professionals, but not explicitly stated as a panel of "experts" for the study itself.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "clinical data" appears to be the established reference.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study evaluates an in vitro diagnostic (IVD) assay (IMMULITE® 2000 3gAllergy™ Specific IgE Assay), which is a laboratory test, not an AI system that assists human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance presented for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay is standalone (algorithm only). This device is an automated in vitro diagnostic test that quantitatively measures allergen-specific IgE. Its performance is evaluated independently of human interpretation of the assay results, though human clinicians will interpret a patient's overall clinical picture, including the assay results.

7. The Type of Ground Truth Used

• Precision and Linearity: Internal quality control materials or spiked samples with known concentrations.
• Specificity (Inhibition): Known relevant inhibitor extracts and negative control samples.
• Clinical Performance: "Clinical data" described as "case histories of suspected clinical reactions to the specific allergen or allergy group" and "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." For the egg allergen, comparison studies were done against previously cleared individual egg constituents (egg white and egg yolk allergens). This is best characterized as clinical documentation/diagnosis.

8. The Sample Size for the Training Set

• The document does not mention a training set. This is not applicable as the device is a chemiluminescent immunoassay, not a machine learning algorithm that requires a training set. The "assay" itself is the device, and its development involves chemical and biological optimization, not algorithm training.

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

• Not applicable, as there is no training set for this type of device.

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid.phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer/co-polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

Description of Device: The IMMULITE® 2000 3gAllergy™ Specific IgE Assay is a solid-phase, two-step, chemiluminescent immunoassay for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. This submission focuses on clearance for eleven additional specific allergens.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for precision, linearity, or inhibition (specificity). Instead, the studies demonstrate the performance and imply that the results obtained are considered acceptable for a device of this type. The table below summarizes the reported performance for each study.

• Bayberry/Sweet gale: 3.38 - 3.97
• Live Oak: 3.18 - 4.79
• Locust Tree: 3.26 - 4.33
• Privet: 3.69 - 3.96
• Red Mulberry: 3.66 - 5.20
• White Bald Cypress: 5.02 - 5.87
• Baccharis: 3.55 - 6.37
• Dog Fennel: 3.54 - 4.06
• Hormodendrum Hordei: 4.29 - 6.32
• Stemphylium Solani: 2.88 - 3.91
• American Cockroach: 4.59 - 5.04
  Total CV% Ranges:
• Bayberry/Sweet gale: 4.85 - 5.38
• Live Oak: 4.97 - 6.21
• Locust Tree: 3.90 - 4.85
• Privet: 4.51 - 5.49
• Red Mulberry: 5.19 - 6.03
• White Bald Cypress: 5.63 - 6.88
• Baccharis: 4.61 - 7.99
• Dog Fennel: 4.46 - 4.90
• Hormodendrum Hordei: 5.64 - 8.46
• Stemphylium Solani: 4.19 - 4.76
• American Cockroach: 5.70 - 6.12 |
  | Linearity | (Implicit) Samples to show linearity across the assay range, with regression statistics indicating a good fit (slope near 1, intercept near 0). | Regression Equations (Y=observed, X=expected):
• Bayberry/Sweet gale: Y=1.01X - 0.03 (Slope: 1.009, 95% CI: 0.988-1.031; Intercept: -0.029, 95% CI: -0.180-0.123)
• Live Oak: Y=1.00X + 0.07 (Slope: 0.997, 95% CI: 0.979-1.015; Intercept: 0.068, 95% CI: -0.022-0.158)
• Locust Tree: Y=0.99X -0.004 (Slope: 0.994, 95% CI: 0.968-1.020; Intercept: -0.004, 95% CI: -0.103-0.096)
• Privet: Y=0.99X + 0.09 (Slope: 0.992, 95% CI: 0.952-1.031; Intercept: 0.092, 95% CI: -0.102-0.285)
• Red Mulberry: Y=1.00X +0.12 (Slope: 1.004, 95% CI: 0.975-1.033; Intercept: 0.116, 95% CI: -0.113-0.346)
• White Bald Cypress: Y=1.01X +0.14 (Slope: 1.006, 95% CI: 0.985-1.028; Intercept: 0.135, 95% CI: -0.082-0.353)
• Baccharis: Y=1.00X - 0.11 (Slope: 0.999, 95% CI: 0.979-1.019; Intercept: -0.114, 95% CI: -0.358-0.131)
• Dog Fennel: Y=1.00X +0.14 (Slope: 1.000, 95% CI: 1.000-1.000; Intercept: 0.138, 95% CI: -0.018-0.294)
• Hormodendrum Hordei: Y=1.01X +0.01 (Slope: 1.007, 95% CI: 0.987-1.026; Intercept: 0.011, 95% CI: -0.101-0.122)
• Stemphylium Solani: Y=0.99X +0.16 (Slope: 0.994, 95% CI: 0.966-1.021; Intercept: 0.158, 95% CI: -0.018-0.334)
• American Cockroach: Y=1.00X +0.05 (Slope: 0.998, 95% CI: 0.979-1.017; Intercept: 0.049, 95% CI: 0.006-0.091) |
  | Specificity (Inhibition) | Target % Inhibition: 50% met by relevant inhibitor extract in a concentration-dependent fashion. | The inhibition studies demonstrated that all tested allergens (Bayberry/Sweet gale, Live Oak, Locust Tree, Privet, Red Mulberry, White Bald Cypress, Baccharis, Dog Fennel, Hormodendrum Hordei, Stemphylium Solani, American Cockroach) were inhibited by their relevant inhibitor extract in a concentration-dependent manner, and the 50% inhibition target was met. For example, for Bayberry/Sweet gale, 48.69% inhibition was achieved at 0.2 mg/mL; for Live Oak, 62.62% at 0.04 mg/mL and 37.67% at 0.008 mg/mL. Specific inhibition percentages are provided in the tables for various inhibitor concentrations. |
  | Clinical Performance | (Implicit) Good agreement between IMMULITE® 2000 3gAllergy results and clinical data (presence/absence of signs, symptoms, and other diagnostic evidence). | Overall Agreement: 81.5%
  Sensitivity (Positive agreement): 257/583 = 44.1% (Calculated from table: Positive results in Clinical group / Total Clinical)
  Specificity (Negative agreement): 1338/1374 = 97.4% (Calculated from table: Negative results in Normal group / Total Normal)
  Total Samples Tested: 1,957 (583 Clinical, 1374 Normal) |

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

• Precision Test Set:

  • For each of the 11 allergens, three positive samples and one negative sample were used. These were assayed in two aliquots per run, across two runs per day, for 20 different days.
  • Provenance: Not specified, but generally, such studies are conducted in-house by the manufacturer.
  • Retrospective/Prospective: Prospective, as it involved controlled experimental conditions.

• Linearity Test Set:

  • For each allergen, two samples were diluted into 5 levels (undiluted + 4 serial dilutions).
  • Provenance: Not specified, likely internal.
  • Retrospective/Prospective: Prospective.

• Specificity (Inhibition) Test Set:

  • A single serum sample or a pool of sera was used for each allergen against a relevant inhibitor extract. A negative sample was also used to measure background response.
  • Provenance: Not specified, likely internal.
  • Retrospective/Prospective: Prospective.

• Clinical Studies Test Set:

  • Total N: 1,957 samples
  • Composition: Samples from "non-atopic individuals" and "atopic patients with case histories of suspected clinical reactions to the specific allergen or allergy group."
  • Provenance: Not specified (e.g., country of origin). The mention of "clinical data" suggests real-world patient samples.
  • Retrospective/Prospective: Not explicitly stated, but the comparison to "case histories" and clinical documentation suggests a retrospective analysis of collected samples with known clinical status.

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

• Precision, Linearity, Specificity: These are analytical performance studies and do not rely on expert ground truth in the same way clinical studies do. The ground truth for these is established by the known concentrations (linearity), or the inherent characteristics of the samples and inhibitors (specificity, precision) as determined by laboratory methods. No external experts are mentioned for establishing ground truth for these analytical tests.

• Clinical Studies:

  • The ground truth for the clinical study was "clinical data," meaning "accompanying clinical information" and "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity."
  • The document does not specify the number of experts, nor their qualifications (e.g., allergists, physicians with specific experience) who established this clinical ground truth.

4. Adjudication Method for the Test Set

• Precision, Linearity, Specificity: Not applicable, as these are quantitative analytical measurements.
• Clinical Studies: The document does not describe an adjudication method for the "clinical data" to establish ground truth. It simply refers to "accompanying clinical information" or "clinical documentation."

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

• No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic assay, not an imaging or interpretation aid for human readers. It provides a quantitative measurement.

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

• Yes, the conducted studies are standalone evaluations of the assay's performance. The IMMULITE® 2000 3gAllergy™ Specific IgE Assay itself is the "algorithm/device" in this context, providing a quantitative value. The clinical study compares its output against clinical information, not against human reader interpretations of results.

7. The Type of Ground Truth Used

• Precision, Linearity, Specificity: Ground truth is established by laboratory standards, known concentrations, and controlled experimental conditions for biochemical reactions.
• Clinical Studies: The ground truth used was "clinical data," which includes "case histories of suspected clinical reactions" and "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This falls under outcomes data / clinical diagnosis as determined by medical professionals.

8. The Sample Size for the Training Set

• The document does not describe a separate "training set" for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay. This device is an in vitro diagnostic assay, typically developed and validated using a different paradigm than AI/machine learning algorithms that require distinct training, validation, and test sets. The studies described are performance evaluations of the assay itself.

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

• As there is no mention of a "training set" in the context of this immunoassay's development as an AI/ML device, this question is not applicable. The development of such assays involves optimizing reagents and conditions rather than training an algorithm on a data set with established ground truths.

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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. Incubation Cycles: 2 × 30 minutes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several performance criteria for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay, including precision, linearity, and specificity. Clinical performance is also assessed.

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

• Precision Studies: Three positive samples and one negative sample were tested for each allergen lot. The testing involved two aliquots of each test sample in two runs per day on 20 different days, following CLSI document EP5-A2. The exact number of individual measurements can be calculated from these parameters (3 positive samples * 2 aliquots/sample * 2 runs/day * 20 days = 240 measurements for positive samples per lot, plus negative control measurements).
• Linearity Studies: For each allergen, two samples were diluted into 5 levels. These 12 samples (2 original + 10 diluted) were tested.
• Specificity (Inhibition) Studies: A single serum sample or pool of sera was used for each allergen. For each inhibition experiment, 70uL of undiluted and 4 levels of 5-fold serially diluted inhibitor extract were mixed with 250uL of sample or pool.
• Clinical Studies: A total of 1,100 samples were used. This included 288 samples from atopic patients with case histories of suspected clinical reactions to the specific allergen or allergy group, and 812 samples from non-atopic individuals.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the clinical studies describe "samples from non-atopic individuals" and "samples from atopic patients with case histories of suspected clinical reactions to the specific allergen or allergy group," which implies a prospective or at least carefully selected retrospective collection for diagnostic relevance.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of image interpretation or complex diagnostic decision-making.

• For the Precision, Linearity, and Specificity (Inhibition) studies, the "ground truth" is based on the inherent biochemical properties of the assay and the measured values, not expert interpretation.
• For the Clinical Studies, "clinical data" was used as the reference. This "clinical data" is described as "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity" and "case histories of suspected clinical reactions." This implies that the ground truth was established by medical professionals (e.g., allergists, physicians) based on patient history, symptoms, and other diagnostic findings; however, the specific number and qualifications of these experts are not provided in this document.

4. Adjudication method for the test set:

Not applicable. The types of studies described (analytical performance and comparison to clinical documentation) do not involve adjudication methods like those used for expert consensus in medical image analysis.

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 versus without AI assistance:

Not applicable. This document describes an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, the studies presented are all standalone performance evaluations of the IMMULITE® 2000 3gAllergy™ Specific IgE Assay itself (the "device" being the assay system), without human-in-the-loop interaction for interpretation beyond standard laboratory procedures. The device provides a quantitative measurement of allergen-specific IgE.

7. The type of ground truth used:

• Precision, Linearity, Specificity: Ground truth is based on physical and chemical measurement principles and established scientific methods for evaluating assay performance (e.g., known concentrations for linearity, defined inhibition protocols for specificity).
• Clinical Studies: The ground truth used was "clinical data," consisting of "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity" and "case histories of suspected clinical reactions" to specific allergens. This can be categorized as outcomes data and expert clinical assessment.

8. The sample size for the training set:

The document describes performance evaluation studies and does not refer to a "training set" in the context of machine learning or AI development. The studies are for validating the assay's performance against established clinical and analytical benchmarks.

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

Not applicable, as there is no mention of a "training set" in the provided document. The studies focus on analytical validation and clinical concordance of the assay itself.

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