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The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. 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 allergist/immunologist offices.

The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.

Here's an analysis of the provided text to extract acceptance criteria and study details for the Kenota 1 Total IgE device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for semi-quantitative classification are implied by the "Percent in ATE" (Allowable Test Error) within the method comparison study, where ATE means the result is within one category of the comparator. While explicit thresholds for numeric precision are provided, the primary acceptance for classification appears centered around this categorical agreement.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Method Comparison Study: 357 samples were used for comparison analysis out of 411 eligible subjects (6 to 80 years).
   • Data Provenance: Subjects were "recruited as representative of the intended use population, for patients with eczema or atopy coming in for regular appointments to the allergy specialty care clinics." Data was collected from three CLIA-waived sites in the US (likely prospective, given the recruitment and paired sample collection for the study).
   • Fingerstick Repeatability Study: 355 fresh fingerstick whole blood samples.
   • Data Provenance: Conducted in three CLIA-waived sites in the U.S. (likely prospective).
   • Reference Interval Study: 117 fingerstick samples.
   • Data Provenance: Collected from adult (N=95, 22-79 years) and pediatric (N=22, 8 to <22 years) volunteer donors from populations in North Carolina, Virginia, and Minnesota, USA (likely prospective).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
   For the method comparison study, the ground truth was established by a predicate device: "ImmunoCAP Total IgE (K161899)", not by human experts. The predicate device is a quantitative measurement system for total IgE. The text does not mention human experts establishing ground truth for the test set.

3. Adjudication Method for the Test Set:
   Not applicable, as the ground truth was based on a predicate device, not expert consensus requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
   No, an MRMC comparative effectiveness study was not done. The study compares the Kenota 1 device's performance against a predicate device, not human readers with and without AI assistance.

5. If a Standalone (Algorithm Only) Performance Was Done:
   Yes, the entire performance section, including analytical studies (precision, linearity, interference, detection limit) and comparison with the predicate device, represents a standalone performance evaluation of the Kenota 1 Total IgE system. It assesses the device's accuracy and reliability as a direct test system.

6. Type of Ground Truth Used:

   • Method Comparison Study: The ground truth was established by the predicate device, ImmunoCAP Total IgE (K161899). This is a legally marketed quantitative test system for total IgE.
   • Analytical Studies (e.g., Precision, Linearity, Detection Limit, Interference): Ground truth was established through spiked samples, pooled samples, or samples with known IgE concentrations measured by validated quantitative laboratory methods or reference materials (e.g., WHO 3rd International Standard Human IgE).

7. Sample Size for the Training Set:
   The document does not provide details on a separate training set for the device itself. The studies described are performance validation studies, usually analogous to a test set for a machine learning model, rather than a training set. For in vitro diagnostic devices like this, calibration (9-level multipoint calibration performed at the manufacturing site) is part of the "training" process. The calibrators used were 0, 2.17, 6.2, 18.6, 37.2, 93, 310, 620, and 930 kU/L.

8. How the Ground Truth for the Training Set Was Established:
   As mentioned above, the device itself is an immunoassay system, not an AI/ML algorithm requiring a distinct "training set" in the conventional sense. Its "training" or calibration involves tying its measurements to a recognized standard.

   • Calibration Ground Truth: The working calibrators for the Kenota 1 Total IgE were "traceable to the primary reference material WHO 3rd International Standard Human IgE (11/234)." This international standard serves as the ground truth for establishing the device's measurement scale.

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Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric.

The provided document outlines the acceptance criteria and study results for the Quantia IgE assay, a device for quantitatively determining total IgE in human serum or plasma. It's important to note that this document is a 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device after a modification, rather than a comprehensive de novo approval study. Therefore, some information typically found in a de novo clinical trial report (e.g., specific details on training set size, number of experts for training ground truth) might not be explicitly detailed.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance characteristics presented and their comparison to the predicate device or established clinical standards (e.g., CLSI guidelines). The document focuses on demonstrating that the modified device performs as well as the predicate and meets relevant analytical performance metrics.

The table clearly shows that the modified device's performance metrics are either improved (e.g., lower LoD, LoQ, extended stability) or remain comparable to the predicate device, demonstrating that the device meets or exceeds the previous performance. The linearity range was expanded downwards from 25.0 to 20.0 IU/mL. The precision values reported for the subject device are well within the specified acceptance criteria for the predicate.

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

The document provides sample sizes for various analytical validation studies:

• Sample Matrix Comparison:
  • Predicate device: Five sets of 52 paired samples were run (total 260 samples).
  • Subject device: Forty paired samples were run (serum vs. various plasma types).
• Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ):
  • LoB: n ≥ 60 replicates of zero-analyte samples.
  • LoD: n ≥ 60 replicates of low-analyte level samples.
  • LoQ: n ≥ 60 replicates of low-analyte level samples.
• Precision:
  • Control (Level I, Mixture I&II, Level II): 50 replicates each (for predicate data summary).
  • Subject device: 80 replicates for "Panel 50 IU/mL", "Control I", "1:1 Mix Control I and II", "Control II", "Panel 800 IU/mL" (tested in a minimum of 2 replicates, twice per day on 20 days).
  • Additionally, 3 native serum pools (Panel A, B, C) were tested with 48 replicates each (in a minimum of 2 replicates, twice per day on 12 days).

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. However, based on the nature of analytical validation studies for an in-vitro diagnostic device, these are typically prospective laboratory studies conducted at the manufacturer's R&D facilities or contracted labs.

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

For an in-vitro diagnostic (IVD) device like Quantia IgE, the ground truth for performance evaluation (e.g., linearity, LoD, LoQ, precision, matrix effects) is established through analytical reference methods and calibrated standards, not human expert review. These studies rely on precise laboratory measurements and established protocols (e.g., CLSI guidelines). Therefore, there are no "experts" in the sense of radiologists reviewing images to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable for analytical performance studies of an IVD. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic imaging or subjective assessments, where human agreement on a diagnosis or finding is crucial. Here, the values are quantitative measurements compared to reference values or statistical criteria.

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

Not applicable. This device is an in-vitro diagnostic assay for measuring total IgE levels, not an imaging device or AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, an MRMC study is irrelevant to its validation.

6. Standalone (Algorithm Only) Performance

This entire submission describes the standalone performance of the Quantia IgE assay, a laboratory test. It is not an "algorithm" in the typical sense of AI, but rather a biochemical assay system. All performance metrics described (linearity, LoD, LoQ, precision, etc.) are characteristics of the assay system itself, without human interpretation beyond standard laboratory procedures and result reporting.

7. Type of Ground Truth Used

The ground truth used for these analytical performance studies is based on:

• Reference Standards/Calibrators: For linearity, LoD, LoQ, and IgE International Standard Recovery, the ground truth is established by using highly characterized, traceable calibrators and reference materials with known concentrations.
• Statistical Definitions/Methodologies: The definitions for LoB, LoD, and LoQ explicitly state how they are determined using a certain number of replicates of zero-analyte or low-analyte samples, and statistical calculations (e.g., 95th percentile, mean + 2 SD).
• Established CLSI Protocols: The studies explicitly state that they were performed based on guidance from CLSI (Clinical and Laboratory Standards Institute) protocols, such as NCCLS EP6-A (now EP06), EP17-A2, EP07-A2, EP37, and EP05-A3. These protocols outline the scientifically accepted methods for establishing analytical performance characteristics.

8. Sample Size for the Training Set

This document describes a "Special 510(k)" for a modification to an existing device (Quantia IgE) to demonstrate substantial equivalence. For IVD analytical performance studies, there isn't a "training set" in the machine learning sense alongside a "test set." The studies performed are the analytical validation studies on actual samples or controls covering the relevant range. The sample sizes for these studies are provided above (e.g., 40 paired samples for matrix comparison, ≥60 replicates for LoD/LoQ, 80 replicates for precision controls, 48 for native serum panels).

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

As explained under points 3 and 7, the concept of a "training set" and "ground truth established by experts" for this type of device and study is not directly applicable. The "training" for such an IVD device happens during its development and optimization phases, where various reagent formulations and assay parameters are tested against known concentration panels to achieve optimal performance. The "ground truth" during this development is based on the known concentrations of calibrators and reference materials, and the adherence to established analytical performance standards. The studies detailed in this 510(k) summary are the formal validation (test set) of the modified device's performance.

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The IgE assay is intended for use in the quantitative determination of Total Immunoglobulin E (lgE) concentration in human serum and plasma (lithium heparin, K2-EDTA, K3-EDTA, K3-EDTA) on Beckman Coulter AU/DxC AU clinical chemistry analyzers. The determination aids in the diagnosis of IgEmediated allergic disorders in conjunction with other clinical findings. For in vitro diagnostic use only.

The Total Immunoglobulin E (IgE) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's AU/DxC AU clinical chemistry analyzers. Each reagent kit contains one buffer reagent (R1), one antibody reagent (R2), and a six-level lot matched calibrator set. The IgE reagent test system utilizes a turbidimetric immunoassay methodology. The AU analyzer measures the change in absorbance at 800 nm to calculate and express the concentration of immunoglobulin E in the test sample based on a stored calibration curve. The IgE assay is traceable to the World Health Organization (WHO) 3rd International Standard 11/234.

The provided document is a 510(k) Premarket Notification for the Beckman Coulter Total Immunoglobulin E (IgE) assay. It describes the device's performance characteristics and how they meet established acceptance criteria, demonstrating substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several tables detailing acceptance criteria and study results for different performance parameters.

Table 1: Method Comparison Summary (from Table 9.1.1)

This table compares the Beckman Coulter IgE Assay (candidate device) against the Roche Elecsys IgE II Assay (predicate device).

Table 2: Precision Performance Summary (from Table 9.2.1)

Note: For Pool 1, the document states criteria of "≤5.0 IU/mL" for repeatability and "≤7.0 IU/mL" for total precision. The reported results are 2.1 IU/mL (repeatability) and 2.3 IU/mL (total precision), which meet these criteria.

Table 3: Analytical Range (Linearity) Study Summary (from Table 9.3.1)

Further breakdown of linearity criteria for individual points in Table 9.3.2 shows "Bias Spec" of 10.0 for values ≤100 IU/mL and "%Bias Spec" of 10.0 for values > 100 IU/mL. All individual points "Pass".

Table 4: Detection Limit Study Summary (LoB, LoD & LoQ) (from Table 9.4.1)

Table 5: Anticoagulant Study Results Summary (from Table 9.7.1)

Table 6: In-Use Stability Study Summary (from Table 9.8.1)

Note: For the stability studies, the acceptance criteria are implicitly met if the "Pass" status is indicated after testing beyond the claimed duration, implying that the mean IgE recovery criteria (within 10 IU/mL or 10% of Day 0 mean) were met.

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

• Method Comparison: 136 fresh serum samples spanning the analytical measuring range. Provenance not explicitly stated.
• Precision: Three lots of IgE reagent, tested using two levels of human serum-based quality control material and three patient pools. The experimental design used duplicate sample analysis twice daily over twenty working days (N=80 results for each control/pool). Provenance not explicitly stated.
• Linearity: 15-level linearity test set of inter-diluted patient pools. Provenance not explicitly stated.
• Sensitivity (LoB, LoD, LoQ): LoB evaluated four unique lots of Immunoglobulin (Ig)-depleted human serum. LoD and LoQ used native patient pools diluted with Ig-depleted serum. Provenance not explicitly stated.
• Analytical Specificity (Interference): Test samples containing various interferents (Hemoglobin, Bilirubin, Lipemia, RF, 21 common drugs and concentrations). Specific sample sizes per interferent are not given but are implied by tables (e.g., "Level Tested"). Provenance not explicitly stated.
• Anticoagulant Studies: Freshly drawn serum and plasma from apparently healthy adult volunteer donors. Five specimen tubes were drawn from each donor: one serum tube and one tube of each type of anticoagulant. Sample sizes listed for each anticoagulant type: Na Heparin (N=55), Li Heparin (N=55), K2 EDTA (N=55), K3 EDTA (N=53). Provenance not explicitly stated.
• In-Use Stability: Three levels of quality control material were evaluated. Specific N is not detailed, but implied by the "classical design for sampling, storage, and testing." Provenance not explicitly stated.

Generally, the data provenance (e.g., country of origin, retrospective/prospective) is not explicitly mentioned for any of the studies in the provided document. The studies appear to be prospective analytical performance studies designed to evaluate the device's technical specifications.

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

This device is an in vitro diagnostic (IVD) quantitative assay for Total IgE. The "ground truth" for such devices is typically established through:

• Traceability to International Standards: The IgE assay is stated to be traceable to the World Health Organization (WHO) 3rd International Standard 11/234. This is a primary method of establishing "ground truth" for quantitative lab tests, where the standard itself defines the "true" concentration.
• Reference Methods: The method comparison study uses a legally marketed predicate device (Roche Elecsys IgE II Assay) as the comparative "truth" or reference standard for patient samples. The predicate device itself would have undergone similar rigorous validation, likely traceable to international standards.

Therefore, for this type of device, the concept of "experts" in the sense of clinicians or radiologists establishing a diagnostic "ground truth" for individual cases (like in an imaging study) is not directly applicable. The "ground truth" for the test set is inherent in the certified international standard and the established performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 consensus are typically used in studies involving subjective interpretation (e.g., imaging reads) to establish a consensus ground truth. For quantitative in vitro diagnostic assays, the "truth" is determined by reference methods, international standards, and analytical evaluation against defined statistical criteria, not by human consensus or adjudication of individual results.

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

Not applicable. This is an in vitro diagnostic (IVD) assay, not an AI-powered diagnostic imaging device or an AI-assisted interpretation tool for human readers. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" do not apply.

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

Yes, the studies presented are all "standalone" in the sense that they evaluate the performance of the analytical instrument and reagent system itself (the "algorithm only" in a broader sense of the measurement process) without direct human intervention in the result generation or interpretation step for the purpose of the performance evaluation. The device provides a quantitative result (IgE concentration), which is then used by clinicians in conjunction with other clinical findings. The performance data (e.g., precision, linearity, sensitivity, method comparison) directly reflects the device's inherent analytical capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this IgE assay is established primarily through:

• International Standards: The assay's traceability to the WHO 3rd International Standard 11/234 is explicitly stated and serves as the ultimate reference for IgE concentration.
• Reference Measurement Procedures/Predicate Device: For method comparison, the Roche Elecsys IgE II Assay serves as the comparative "reference" for patient samples. This predicate device itself is assumed to be traceable to international standards and validated.
• A priori defined analytical specifications: For precision, linearity, and detection limits, the "ground truth" or acceptance criteria are statistically derived technical specifications (e.g., CV limits, bias limits) that the device must meet to be considered analytically robust.

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 because this is not an AI/ML-based device. It is a traditional in vitro diagnostic immunoassay. The performance studies detailed are validation studies for the cleared device.

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

Not applicable, as there is no "training set" in the AI/ML sense for this traditional IVD product. If "training set" broadly refers to materials used during the development and calibration of the assay, the document indicates that the assay is traceable to the WHO 3rd International Standard 11/234, and a six-level lot-matched calibrator set is included, which would be used to establish the calibration curve for the assay.

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For in vitro diagnostic use in the quantitative determination of total IgE in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur®, ADVIA Centaur XP, and ADVIA Centaur XPT systems.

The ADVIA Centaur Total IgE (tlgE) assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies to IqE. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Total IgE (tlgE) assay is intended for use on the ADVIA Centaur family of analyzers. The ADVIA Centaur Calibrator 80 is a set of 2 level calibrators for the assay. Siemens Healthcare Diagnostics recommends the use of commercially available quality control materials with at least 2 levels (low and high).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Device: ADVIA Centaur Total IgE (tIgE) Assay

Purpose of Submission: Addition of plasma (EDTA and lithium heparin) sample claim and updating the detection capability claim.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Specimen Equivalence by Method Comparison:

  • Sample Size: N = 73 for both Dipotassium EDTA Plasma vs. Serum and Lithium Heparin vs. Serum.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's for an in vitro diagnostic device and involves method comparison, it typically involves collected patient samples.

• Detection Capability (LoB, LoD, LoQ) and Interferences:

  • Sample Size: Not explicitly stated how many individual samples were used to determine LoB, LoD, LoQ, or for interference testing. These typically involve a series of measurements on spiked or known concentration samples rather than a large set of patient samples like method comparison.
  • Data Provenance: Not explicitly stated.

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

This submission document primarily focuses on analytical performance of an in vitro diagnostic (IVD) assay and does not involve human expert interpretation of results to establish ground truth in the way a medical imaging AI would. Therefore, this section is not applicable in the traditional sense for this type of device. The "ground truth" for this device's performance is established by the known concentrations of analytes in controls, calibrators, and spiked samples, and comparison to a reference method (in the case of method comparison studies).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an analytical performance study for an IVD assay, not a study involving human reader interpretation requiring adjudication.

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

No. A MRMC study is typically performed for AI-assisted diagnostic imaging devices to evaluate the impact of AI on human reader performance. This submission is for an in vitro diagnostic assay, which does not involve human interpretation of images in this context.

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

This device is a standalone device in terms of its operation. It's an automated immunoassay system (ADVIA Centaur family of analyzers) that quantitatively determines total IgE. Its performance characteristics (detection capability, specimen equivalence, interference) are evaluated as the algorithm/system running independently on samples. There isn't a human-in-the-loop interacting with the direct measurement as there would be with an AI assisting image interpretation.

7. The Type of Ground Truth Used

• Detection Capability (LoB, LoD, LoQ): Established using statistical methods defined by CLSI EP17-A2, relying on repeated measurements of blank samples and samples with known low concentrations of the analyte.
• Specimen Equivalence by Method Comparison: The "ground truth" for the comparison (serum) is considered the established method against which the alternative sample types (EDTA plasma, lithium heparin plasma) are being evaluated. This relies on the accuracy of the serum measurement itself.
• Interferences: Established by spiking known interfering substances at specified concentrations into samples with known IgE concentrations and measuring the resulting bias.

8. The Sample Size for the Training Set

Not applicable. This is an analytical performance study for a chemical assay. There is no "training set" in the machine learning sense for this device. The assay's parameters and calibration are established through laboratory procedures, calibrators, and master curves, not through a data-driven training process in the way an AI algorithm is trained.

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

Not applicable. As there is no "training set" in the AI sense for this device, there is no ground truth established for it. The assay relies on known chemical reactions, calibrated reagents, and master curves set during the assay's development and manufacturing.

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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). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 1000, Phadia 2500 and Phadia 5000. 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 Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum and plasma. 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 Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

The general ImmunoCAP reagents include ImmunoCAP Specific or Total IgE Conjugate, ImmunoCAP Specific or Total IgE Curve Control, ImmunoCAP Specific or Total IgE Calibrators, Specific or Total IgE anti-IgE, Allergen ImmunoCAP carriers (only for determination of Specific IgE), Development solution, Stop Solution and Washing Solution. The method specific reagents consist of individual purified allergen (native or recombinant), covalently coupled to a support in a plastic housing (only for determination of Specific IgE).

Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.

The document describes the ImmunoCAP Specific IgE Assay and ImmunoCAP Total IgE Assay, which are in vitro quantitative assays for measuring allergen-specific and total IgE in human serum or plasma. The primary purpose of this 510(k) submission is to introduce a new Reference Material for the standardization of these assays.

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

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

The document does not explicitly list a table of acceptance criteria with corresponding device performance for the ImmunoCAP Specific IgE Assay and ImmunoCAP Total IgE Assay. The submission is focused on a change in the reference material and proving substantial equivalence to previously cleared devices.

However, the "Conclusion" section (page 6) states: "The safety and effectiveness of the cleared ImmunoCAP Specific and Total IgE systems, intended for the determination of specific and total IgE antibodies, have been established in previous 510(k) submissions. The Reference Material change does not affect the Intended Use or the Indications for Use statements, the fundamental scientific technology, specifications or manufacturing methods of the assays. The verification studies performed demonstrate that the updated ImmunoCAP Specific and Total IgE assays are substantially equivalent to the currently cleared products."

This implies that the acceptance criteria for these assays were established and met in prior 510(k) submissions, and the current submission aims to demonstrate that changing the reference material does not negatively impact the performance against those pre-established criteria. The specific performance metrics themselves (e.g., precision, accuracy, linearity) are not detailed in this document for the current change.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions two studies conducted to evaluate the impact of the new reference material:

• "Concentration determination of two stock solutions used for production of ImmunoCAP Specific IgE Calibrators"
• "Evaluation of clinical negative and positive patient samples in ImmunoCAP Specific IgE"

Sample Size: The exact sample sizes for these studies are not provided in this document.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies involve laboratory-based comparisons of calibration and patient samples, rather than subjective interpretation by experts. The "ground truth" here would relate to the accurate measurement of IgE concentration, which is assessed through reference materials and comparative analysis with previously established methods, not expert consensus in the same way it would be for imaging diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where multiple human readers or experts are involved in interpreting results which are then subject to a consensus process. The studies described are laboratory-based assays comparing different versions of a product.

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

An MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging diagnostics or other AI-assisted diagnostic tools where human interpretation is a key component. The ImmunoCAP assays are in vitro diagnostic tests that produce quantitative results, not interpretations by human readers.

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

The ImmunoCAP assays are inherently "standalone" in the sense that they are laboratory tests that generate quantitative results automatically using instruments (Phadia 100, 1000, 2500, 5000) and associated software after the assay procedure. There isn't a human-in-the-loop performance component in the measurement itself, though clinical interpretation of the quantitative results by a healthcare professional is part of their intended use. The performance characteristics would be assessed based on the accuracy and precision of the system's measurements. The document implies laboratory "verification studies" were performed to compare the new device to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the ImmunoCAP assays, as indicated by the "Description of change" (page 6), is linked to international standards for serum IgE. Specifically, the new Reference Material is traceable to the 3rd WHO International Standard (300 WHO IRR) for serum IgE (11/234), replacing the 2nd WHO IRR. This means the accuracy of the device's measurements is evaluated against these established international biological reference standards.

8. The sample size for the training set

This information is not provided in the document. For in vitro diagnostic assays, "training set" is not a standard term in the same way it is for machine learning algorithms. The development and calibration of such assays typically involve optimizing reagents and protocols using a range of known standards and samples, but these are not explicitly referred to as "training sets."

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

As noted in point 8, the concept of a "training set" with established ground truth is not explicitly addressed in the document in the context of algorithm development. However, the calibration and standardization of the ImmunoCAP assays rely on established WHO International Standards for serum IgE. These standards themselves are developed through extensive collaborative studies involving numerous laboratories and experts to assign specific IgE concentration units, thereby serving as the "ground truth" reference for calibration and measurement accuracy.

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ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or plasma. 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 Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

ImmunoCAP Total IgE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.

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

Phadia 100. Phadia 250. Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.

Anti-IgE, covalently coupled to ImmunoCAP, reacts with the total IgE in the patient sample. After washing, enzyme labeled antibodies against IgE are added to form a complex. Following 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 fluorescence is directly proportional to the concentration of IgE in the sample. The higher the response, the more IgE is present in the sample. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

This document is a 510(k) summary for the ImmunoCAP Total IgE System. The submission describes a change to the format of the Directions for Use, merging three existing documents into one, with minor editorial changes. The summary explicitly states that "The change does not affect the Intended Use / Indications for Use Statement and it does not affect the safety or effectiveness of the ImmunoCAP Total IgE system, as cleared under K964152."

Therefore, this 510(k) submission does not include any new studies or acceptance criteria to prove the device meets performance standards. It relies on the previously established substantial equivalence and performance data from the predicate device (K964152).

Given this, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text, as no such information is presented in this specific submission.

If you have access to the original 510(k) (K964152) for the ImmunoCAP Total IgE, that document would contain the efficacy studies and acceptance criteria for the device itself.

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Dimension Vista™ IGE Flex® reagent cartridge: The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L. M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Dimension Vista™ IGE Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).

This submission describes the Dimension Vista™ IGE Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H for the quantitative determination of Immunoglobulin E (IgE). The study aimed to demonstrate equivalent performance to a legally marketed predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, slope, or intercept. Instead, it implies that a strong correlation and "equivalent performance" between the new device and the predicate device would be considered acceptable. The reported performance is a regression analysis of the method comparison study.

Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Latex IgE mono assay and the Dimension Vista " IGE assay." This statement, along with the high correlation coefficient, suggests the reported performance met the unstated equivalence criteria.

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

• Sample Size for Test Set: 120 serum and plasma samples.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were human serum and plasma. It doesn't specify if the data was retrospective or prospective, but method comparison studies are typically prospective or use banked retrospective samples to evaluate the new device against a predicate. Given the typical nature of device validation, it's likely these were distinct samples collected for the purpose of the comparison.

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

This type of in vitro diagnostic device (IVD) for quantitative measurement does not typically rely on "expert consensus" for ground truth in the same way an imaging or diagnostic AI model would.

• Ground Truth Establishment: The "ground truth" for the test set was established by running the samples on the predicate device, the Dade Behring N Latex IgE mono assay on the BN ProSpec® System.
• Number and Qualifications of Experts: Not applicable in the context of this type of quantitative IVD comparison. The performance of the predicate device serves as the reference, which has its own established accuracy and precision validated through previous studies.

4. Adjudication Method for the Test Set

Not applicable. The comparison involves quantitative measurements from two different analytical systems, not subjective interpretations requiring adjudication.

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

• Was an MRMC study done? No. This submission pertains to an in vitro diagnostic device for quantitative IgE measurement, which does not involve human readers interpreting cases or AI assistance in a diagnostic workflow. Therefore, an MRMC study is not relevant.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

• Was a standalone study done? Yes, in essence. The method comparison study directly evaluated the Dimension Vista™ IGE assay (algorithm/device only) against the predicate device. The output is a numerical value, and there is no human-in-the-loop interpretation or intervention in generating this primary result.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this comparison study was the quantitative IgE values obtained from the predicate device: the Dade Behring N Latex IgE mono assay on the BN ProSpec® System. This is a form of comparative reference measurement, where the established method (predicate) serves as the benchmark.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a "training set" in the context of machine learning. For IVDs, the development and calibration of the assay (reagents, calibrators, controls) are typically done through extensive internal studies (which would involve numerous samples for optimization, calibration curve generation, and verification of analytical performance characteristics like linearity, precision, etc.) before the final method comparison study. The 120 samples discussed in the method comparison are best considered a validation/test set for the final, developed assay.

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

• Ground Truth Establishment for Training Set: Since a "training set" in the machine learning sense isn't explicitly described, the concept of ground truth for training would relate to the development and calibration of the assay itself. This would involve:
  • Reference materials: Using internationally recognized IgE reference materials or purified IgE standards with known concentrations for calibrating the assay and defining the optimal reagent formulation and reaction conditions.
  • Known samples: Running samples with previously established IgE concentrations (e.g., from other validated methods) to confirm the assay's ability to accurately measure them.
  • Analytical studies: Performing studies to establish linearity, limit of detection, precision, and other analytical performance characteristics, where "ground truth" is defined by the expected behavior of the assay with controlled samples.

The document focuses on the final validation of the Dimension Vista™ IGE assay against a predicate, rather than the developmental steps involving "training."

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Quantia IqE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunoglobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with Quantia Ferritin, Quantia Myoglobin and Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879 and also cleared for use with quantex Myoglobin K042982). For in vitro diagnostic use.

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Quantia IgE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunodobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with the Quantia Ferritin, the Quantia Myoglobin and the Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin. reference K040879 and also cleared for use with quantex Myoglobin K042982) For in vitro diagnostic use.

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

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

Acceptance Criteria and Reported Device Performance

The document implies acceptance criteria by demonstrating substantial equivalence to the predicate device. The key performance indicators used for this determination are related to method comparison and precision.

Study Details

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

   • Test Set Sample Size: 101 samples
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved evaluating IgE levels ranging from 10 to 2269 IU/mL. It is likely retrospective, comparing an existing set of samples against two different assays.

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

   • Not applicable for this type of in vitro diagnostic device study. The "ground truth" for the method comparison is the measurement obtained from the predicate device.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative assay comparison, not an interpretation-based study requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device measuring a biomarker, not an imaging or interpretive AI system involving human readers.

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

   • Yes, this study represents a standalone performance evaluation of the Quantia IgE assay (an algorithm in the sense of an automated test system) as it directly measures IgE levels and compares them to a predicate device without human intervention in the measurement process itself.

6. The type of ground truth used:

   • For the method comparison study, the measurement obtained from the UniCAP Total IgE Fluoroimmunoassay (K964152) was used as the reference or "ground truth" for comparison. The precision study used known control materials.

7. The sample size for the training set:

   • Not applicable as this is not a machine learning / AI model that requires a discrete training set. The "training" for such a system would involve the assay's development and optimization, which isn't described in terms of a specific data set size here.

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

   • Not applicable for the reason stated above.

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The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay.

For in vitro diagnostic use.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "K-Assay® Total IgE Assay" and "K-Assay® IgE Calibrator." This document primarily communicates the FDA's decision that the device is substantially equivalent to legally marketed predicate devices.

It does NOT contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information on expert ground truth establishment (number, qualifications, adjudication method).
• Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.

This type of information would typically be found in the device's original 510(k) submission, specifically in the performance study sections, which are not included in this FDA decision letter. The letter confirms clearance but does not provide the underlying study data.

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Lacrytest is a rapid immunoassay for the detection of total IgE in tears, Semi-quantitative detection of total IgE In tears (< 2.5 KIU/liter, 2.5 - 10 kIU/liter, 10 - 40 klU/liter, and > 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.

Lacrytest (marked CE) allows the rapid and specific determination of total IgE in tears (in vivo/in vitro). This test is a simple and rapid immuno-chromatographic test, which enables the identification of allergic conjunctivitis in one single step. Its main advantage is that it can be done in vivo without being invasive. The speed and simplicity of this unique test enables a better and faster treatment of the patient. Lacrytest is a ready-to-use strip, with all the necessary reagents already incorporated into it. No instrumentation or prior provision of tear samples is required: Lacrytest uses monoclonal and polyclonal antibodies to detect total IgE in tears. Lacrytest gives results from just one teardrop, and is placed in contact with the patient's eye for less than three minutes, causing minimum discomfort when compared to the Schirmer assay. Doctors do not have to take tear sample, and an indicator appears on the strip when enough tear fluid has been absorbed. The test strip is then soaked with sterile water and the evaluation of amount of total IgE detected. The results appear in the form of easily visible red-violet lines in the presence of total IgE levels greater than 2,5 KUI/L (the detection limit). These results are stable and can be archived. The test can be used in the laboratory, in the doctor's surgery or on a home visit.

Here's an analysis of the provided text to extract the requested information about the Lacrytest device:

Acceptance Criteria and Device Performance

The acceptance criteria for the Lacrytest device are implicitly established by comparison to the predicate device, UniCAP total IgE FEIA Assay. The document primarily focuses on demonstrating comparable sensitivity and specificity.

Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document describes the Lacrytest as having "slightly lower sensitivity than UniCAP and an equal specificity." This implies that the acceptance criteria for sensitivity were flexible enough to accommodate a minor difference. The precision data comparison also highlights areas where Lacrytest's performance differs (e.g., higher CV at low levels).

Study Details

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

• Sample Size: 165 human serum samples were used for comparative studies against UniCAP.
• Data Provenance: The document does not explicitly state the country of origin for these 165 human serum samples, nor does it specify if the data was retrospective or prospective. It only mentions "human serums."

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 ground truth for the test set in the context of the comparative study. The ground truth appears to be based on the results obtained from the predicate device, UniCAP.

4. Adjudication method for the test set

• No adjudication method is described for the test set. The comparison is directly made against the UniCAP results. The "human reading of the device" is cited as a factor for some agreement differences, but no specific adjudication process for discrepancies is detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This device is a rapid immunoassay test, not an AI-assisted diagnostic tool for human readers.

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

• The Lacrytest is a standalone immuno-chromatographic test. Its performance metrics (sensitivity, specificity, precision) are measured for the device itself.
• However, the interpretation of the results involves "human reading," as noted for the agreement of results ("mainly explained by the human reading of the device"). This suggests that while the test is standalone, its ultimate performance in practice can be influenced by human interpretation of the visual lines.

7. The type of ground truth used

• The primary ground truth for the performance study (sensitivity and specificity) was established by comparison to the UniCAP total IgE FEIA Assay, which served as the reference method. This is a form of reference standard comparison.
• For the "normal healthy subjects" section, the ground truth was presumably based on clinical diagnosis or established healthy status.

8. The sample size for the training set

• The document does not mention a "training set" as would be relevant for machine learning algorithms. The performance data provided is for the device as evaluated, implying a validation or verification set against a reference. This is a traditional immunoassay, not an AI-based system that undergoes a separate training phase.

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

• As there is no mention of a training set, the establishment of ground truth for such a set is not applicable to the information provided.

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