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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.

Device Description

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

Phadia 100, Phadia 250, Phadia 1000, 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 allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

AI/ML Overview

This document is a 510(k) Summary for the ImmunoCAP Specific IgE, Allergen Component rAra h 6, Peanut device (K173726). It describes the device's indications for use and performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "The performance characteristics of the new ImmunoCAP Allergen Component was established through verification studies of Precision, Lot-to-Lot Reproducibility, Limit of Detection, and Stability. Inhibition studies verified the analytical specificity of the allergen component."

While specific numerical acceptance criteria and reported device performance for each of these verification studies are not provided in this summary, the conclusion states: "The safety and effectiveness of the cleared device ImmunoCAP Specific IgE system for the determination of specific IgE antibodies have been established in previous 510(k) submissions. This submission covers the addition of a new ImmunoCAP Allergen Component to the existing ImmunoCAP Specific IgE assay." This implies that the new component met the necessary performance standards.

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

Sample Size for Test Set: The document mentions "clinical samples, as well as samples from healthy, non-atopic donors" were used for comparison with the predicate device. However, the specific sample size for the test set is not provided.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The device is an in vitro diagnostic test, and ground truth would typically be established by clinical diagnosis and/or other established testing methods, rather than by human expert review of images, as might be the case for imaging AI.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The context of this question (e.g., 2+1, 3+1) typically relates to expert review of ambiguous cases, which is not described for this in vitro diagnostic device validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

Not applicable. This device is an in vitro diagnostic assay, not an AI intended to assist human readers in interpreting medical images. Therefore, an MRMC study and
effect size for human reader improvement with AI assistance are not relevant.

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

Yes, in essence. The validation described is for the performance of the assay itself, which is a standalone measurement of allergen-specific IgE. The "ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE...to be used with instruments Phadia 100, Phadia 1000, Phadia 2500 and Phadia 5000." The performance characteristics (Precision, Lot-to-Lot Reproducibility, Limit of Detection, Stability, Analytical Specificity) are evaluated for the assay's ability to accurately measure IgE levels.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation would typically be:

Clinical Diagnosis: "an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings."
Predicate Device Comparison: The new component was "compared with the extract based predicate device with the use of clinical samples." This implies that the predicate device's results served as a comparative ground truth.
Known Samples: The use of "samples from healthy, non-atopic donors" would provide a ground truth of low or negative IgE levels.
Known Spikes/Concentrations: For precision, stability, and limit of detection studies, ground truth is established by using samples with known concentrations or by spiking known amounts of analyte.

8. The Sample Size for the Training Set

This document describes the validation of a new allergen component for an existing ImmunoCAP assay. These are chemical/biological assays, not AI algorithms that require a "training set" in the machine learning sense. Therefore, a training set size is not applicable/provided. The "training" here refers to the development and optimization of the assay's reagents and protocols.

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

Similar to point 8, the concept of a "training set" and establishing its ground truth in the context of machine learning does not directly apply to the development of this in vitro diagnostic assay. The development process would involve optimizing reagent formulations and reaction conditions, with "ground truth" reflecting the desired assay characteristics (e.g., specific binding, sensitivity, dynamic range) against known standards and clinically relevant samples.

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K Number

K150854

Device Name

ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut

Manufacturer

PHADIA AB

Date Cleared

2015-12-14

(258 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

k051218,k962274,k974580

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

This document, referenced as K150854, is a 510(k) premarket notification for ImmunoCAP Specific IgE, specifically the addition of new allergen components (rCor a 14, nCor a 9, rJug r 1, rJug r 3, rAna o 3). The core of the document is an FDA letter of substantial equivalence and a 510(k) summary, which outlines the device, its intended use, and performance characteristics.

Based on the provided text, the device in question is an in vitro diagnostic assay (ImmunoCAP Specific IgE) used for quantitative measurement of allergen-specific IgE in human serum or plasma. The submission K150854 is for the addition of new ImmunoCAP Allergen Components to an already cleared and established system (referenced under K051218).

The document does not describe a typical AI/ML-based device that would require an MRMC study or AI-specific ground truth methodologies. Instead, it describes an in vitro diagnostic test for allergen-specific IgE antibodies. Therefore, the questions related to AI/MRMC and image-based ground truth establishment are not directly applicable. I will interpret the questions in the context of an in vitro diagnostic test.

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

Device: ImmunoCAP Specific IgE, with newly added ImmunoCAP Allergen Components (rCor a 14, nCor a 9, rJug r 1, rJug r 3, rAna o 3).

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The performance characteristics of the new ImmunoCAP Allergen Components were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the analytical specificity of the allergen components."

While specific numeric acceptance criteria are not explicitly stated in this summary, the reported performance is that these characteristics were "established" and "verified". For an in vitro diagnostic device, these are standard performance characteristics that need to be within predefined acceptable ranges.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Demonstrates appropriate repeatability and reproducibility (e.g., within established CV% limits)	"Established through studies of Precision including Lot-to-Lot Reproducibility"
Lot-to-Lot Reproducibility	Consistent results across different manufacturing lots (e.g., within established CV% limits)	"Established through studies of... Lot-to-Lot Reproducibility"
Linearity	Accurate measurement across the reportable range (e.g., results proportional to concentration)	"Established through studies of... Linearity"
Limit of Detection (LoD)	Ability to detect the smallest amount of analyte (e.g., determined and met performance specifications)	"Established through studies of... Limit of Detection"
Analytical Specificity	Measures only the intended analyte without interference from other substances	"Inhibition studies verified the analytical specificity of the allergen components."
Comparison to Predicate Devices	Results from new components correlate well with existing extract-based predicate devices (e.g., strong correlation coefficient, acceptable agreement)	"The new ImmunoCAP Allergen Components were compared with the extract based predicate devices with the use of clinical samples, as well as samples from healthy, nonatopic donors." (Implicitly, the results met a pre-defined equivalence or non-inferiority standard to be cleared.)

2. Sample Size and Data Provenance

Test Set Sample Size: The document mentions "clinical samples, as well as samples from healthy, nonatopic donors" were used for comparison with predicate devices. However, the specific number of samples (N) for these studies or for the precision, linearity, and LoD studies is not specified in this 510(k) summary.
Data Provenance: Not explicitly stated. The manufacturer is Phadia AB located in Sweden, and the distributor is Phadia US Inc. in Michigan, USA. It's common for such studies to involve samples from multiple geographical locations, but this is not mentioned. The data provenance is assumed to be from a clinical setting, as "clinical samples" are mentioned.
Retrospective or Prospective: Not explicitly stated. For "clinical samples", they could be either.

3. Number of Experts and Qualifications for Ground Truth

This question is typically relevant for interpretative devices (e.g., imaging AI). For an in vitro diagnostic measuring a biomarker (IgE levels), the "ground truth" is typically the analyte concentration itself, measured using established laboratory methods or reference standards, rather than expert interpretation of a complex image. Therefore, the concept of "experts" establishing ground truth in the typical AI/MRMC sense does not directly apply here.

The "ground truth" for the test samples would be their known IgE levels for the specific allergens, determined by reference methods or clinical diagnosis supported by established criteria (e.g., patient history, other diagnostic tests for allergy). The "experts" involve qualified laboratory personnel following standard operating procedures and clinicians using and interpreting the results in conjunction with other findings.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of adjudicating disagreements among human readers/interpreters. For an in vitro diagnostic test, the "ground truth" is typically quantitative, established by the assay itself (or a reference assay), and consistency/accuracy is verified against known standards or reference methods.

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

Done? No, an MRMC study was not done. This type of study is specifically designed for AI-assisted image interpretation to assess whether AI improves human reader performance. This device is an in vitro diagnostic assay, not an imaging AI system.
Effect Size: Not applicable as no MRMC study was performed. The device's performance is assessed by its ability to accurately and precisely quantify IgE, not by its impact on human reader interpretation.

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

Done? Yes, in a sense, the device's performance characteristics (precision, linearity, LoD, analytical specificity) are assessed as a standalone assay. The ImmunoCAP Specific IgE system with its instruments (Phadia 100, 1000, 2500, 5000) calculates results automatically. The output is a quantitative value of allergen-specific IgE. Human involvement is in sample preparation, loading, and interpretation of the final quantitative results in a clinical context. The performance characteristics studies described are inherently "standalone" in verifying the analytical accuracy of the assay itself.

7. Type of Ground Truth Used

The ground truth for an IVD like this would be:

Reference Standards/Calibration: For linearity, LoD, and precision, the ground truth is often established by using samples with known, carefully prepared concentrations of the analyte (IgE antibodies).
Reference Methods/Predicate Devices: For comparative studies, the results obtained from the new components are compared against extract-based predicate devices which are already established as providing reliable measurements of allergen-specific IgE.
Clinical Samples: Samples from patients with known allergic status (diagnosed by clinical findings, patient history, other diagnostic tests) and healthy, non-atopic controls are used to assess the device's ability to differentiate between populations, aligning with its intended use in clinical diagnosis.

8. Sample Size for the Training Set

This term "training set" is primarily relevant for AI/ML models. For an IVD, the development and optimization of the assay would involve various experimental samples. The document does not specify a "training set" sample size in the AI/ML context. The development process would have involved numerous runs and samples to optimize the assay formulation, protocols, and instrument parameters, but these are not typically quantified as a "training set" in a 510(k) summary for an IVD.

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

Not applicable as there is no "training set" in the AI/ML sense. The "ground truth" for assay development and validation involves:

Biochemical principles: The assay is based on known antigen-antibody binding reactions.
Analytical standards: Use of purified IgE, allergen standards, and calibrators with assigned values.
Comparison to existing methods: The assay development would have aimed to produce results consistent with established and reference methods for allergen-specific IgE measurement.
Clinical correlation: Validation against clinical diagnosis of allergy to ensure the assay provides useful information in a clinical context.

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