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ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP® is a device for the in vitro semiquantitative measurement of IgA or IqG antibodies specific for gliadin in human serum. ImmunoCAP/UniCAP Gliadin IgAllgG ImmunoCAP is intended to be used with the instrument ImmunoCAP/UniCAP together with reagents as stated in the Directions for Use provided with ImmunoCAP/UniCAP Specific IgA and ImmunoCAP/UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.

ImmunoCAP/UniCAP Specific IgA is an in vitro test system for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP/UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the ImmunoCAP/UniCAP Specific IgA system. ImmunoCAP/UniCAP Specific IgA assay is to be used with the instrument ImmunoCAP/UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

The Pharmacia ImmunoCAP Immunodiagnostic System is a fully integrated and automated system for immunodiagnostic testing. ImmunoCAP System is comprised currently of an instrument family, ImmunoCAP 100/250/1000 and individual assay products - Fluoro enzyme immunoassays reagents for the measurement of Immunoglobulin IgE, IgG, IgA, with ImmunoCAP Allergens/Antigens (solid phase components which contain the specific allergen/antigens to which antibodies are going to be measured), and Software Accessories.

ImmunoCAP instruments are designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP cariers are loaded into the instrument and the process, which takes about 2.5 hours, is started. A laboratory report is automatically printed when the process is ended.

ImmunoCAP instruments can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs. Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the instrument system software.

ImmunoCAP® System Information Data Manager (IDM) is intended to be used with a Windows-based PC operating up to five ImmunoCAP instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to, a connected mainframe computer.

ImmunoCAP Specific IgA is a fluoro enzyme immunoassay for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component (ImmunoCAP carrier). Specific IgA antibodies in the patient serum or plasma specimen react with the antigens of interest, in this submission, Gliadin, which are covalently coupled to the ImmunoCAP carrier solid phase.

After washing away non-specific IgA, enzyme labeled antibodies against IgA (ImmunoCAP/UniCAP Specific IgA Conjugate) is added to form a complex. After incubation, unbound enzyme-anti-IgA is washed away and the bound complex is incubated with a development agent. After stopping the reaction, the response of the eluate is measured. The response is directly proportional to the concentration of IgA in the serum sample.

The modification consists of a change from polyclonal Rabbit anti-human IgA antibodies to Mouse monoclonal anti-human IgA antibodies in the reagent ImmunoCAP/UniCAP Specific IgA Conjugate. No other reagents have been changed.

Here's a breakdown of the acceptance criteria and the study details for the ImmunoCAP® Specific IgA -/Gliadin/ Modified Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The core of this submission is a device modification, so the acceptance criteria are primarily focused on demonstrating substantial equivalence to the predicate device after the change. The main acceptance criteria appear to be a "good correlation" between the modified and predicate devices over the measuring range, and that any differences are "fully acceptable" for the intended use, without changes to the indications for use or clinical claims.

Note: The document does not explicitly state numerical thresholds for "good correlation," "small difference," "very good conformance," or "totally acceptable." These terms represent the qualitative acceptance criteria used in this summary.

Study Details

This submission describes a comparative study to demonstrate substantial equivalence following a device modification.

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

   • Sample Size: 182 samples
   • Data Provenance: Not explicitly stated, but the samples included "Gliadin specific IgA positive, negative and healthy individuals." Given that the manufacturer is in Sweden (Pharmacia Diagnostics AB, Uppsala, Sweden), it is plausible the samples are from this region, but this is not confirmed. The study appears to be retrospective as it's comparing a modified device to the previous version using existent samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study is a technical comparison of two versions of a diagnostic test (modified vs. predicate), not a diagnostic study requiring expert ground truth for clinical cases. The ground truth for the samples would be their known status (Gliadin specific IgA positive, negative, healthy) based on prior established diagnostic methods or clinical criteria.

3. Adjudication method for the test set: Not applicable, as this was a direct comparison of assay results rather than a clinical adjudication of patient cases.

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: Not applicable. This is not an AI/CAD device. It's a laboratory diagnostic assay for measuring specific IgA antibodies.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laboratory diagnostic assay. The "algorithm" here refers to the assay's chemical and enzymatic reactions, and the instrument's processing of results, which is inherently "standalone" in generating a quantitative measurement. Human intervention is required for sample collection, loading, and result interpretation in a clinical context.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the 182 samples was their status as "Gliadin specific IgA positive, negative and healthy individuals." This implies that their status was determined previously through established diagnostic methods for celiac disease or IgA levels, and/or clinical assessment. The document does not specify the exact nature of this "ground truth" (e.g., biopsy-confirmed celiac, other diagnostic tests).

7. The sample size for the training set: Not applicable. This is a device modification study for a laboratory assay. There's no "training set" in the context of machine learning or AI. The assay itself has established reagents and protocols validated through previous development and regulatory submissions (like the predicate device in K982533).

8. How the ground truth for the training set was established: Not applicable, as there is no training set in this context.

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UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific 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, as well as physician office laboratories.

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. The system includes reagents (Conjugate, Calibrators, Curve Controls, Specific IgE ImmunoCAP and Allergen ImmunoCAP Carriers, Development Kit, Washing Solution) and ImmunoCAP instruments with built-in software. The assay principle involves allergen coupled to ImmunoCAP reacting with specific IgE in the patient sample, followed by incubation with enzyme labeled antibodies against IgE. After washing, the bound complex is incubated with a developing agent, and the fluorescence of the eluate is measured. The fluorescence response is transformed to concentrations using a calibration curve. The modification is a minor change to the calibrator system to extend the technical measuring range below 0.35 kUx/l by adding a 0 kU/l Calibrator and removing the 50 kU/l Calibrator, keeping 6 calibrators in total (0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l).

Here's a breakdown of the acceptance criteria and the study details for the UniCAP Specific IgE device modification, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the sample size used for the test set.
• It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The study focuses on evaluating the modification of the calibrator system rather than clinical performance on patient samples in this specific filing.

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

This information is not provided in the document. The study described focuses on the technical performance of the device's calibration system, not on establishing a ground truth for clinical diagnosis of allergic disorders using expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a technical comparison of calibration curves and determination of Limit of Quantitation, not a study involving human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document describes a technical modification and verification of the device's measurement range and calibration.

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

Yes, in a sense, a standalone evaluation was performed. The study focused on the technical performance of the changed calibrator system as implemented in the device, without involving human interpretation or interaction during the measurement process. The device's instrument system processes all steps and prints results automatically.

7. The Type of Ground Truth Used

The "ground truth" for this study was primarily:

• Comparison against the previous/current calibration curves to assess conformity.
• Adherence to established laboratory protocols for determining Limits of Detection and Quantitation (NCCLS document EP-17A), which serves as a technical standard for assessing the accuracy of the assay's lower measurement range.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or algorithm development. The study is about a modification to the calibrator system of an existing in vitro diagnostic device. The "calibration" of the device itself uses ImmunoCAP Specific IgE Calibrators 0-100 (which were modified in this update to 0, 0.35, 0.7, 3.5, 17.5 and 100 kU/l as the six points).

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

Given that this is a modification to an existing in vitro diagnostic assay and not an AI/machine learning device, the concept of a "training set ground truth" as it applies to AI is not directly relevant.

For the purpose of the device's operation, the "ground truth" for the calibrators is established by their known concentrations (e.g., 0, 0.35, 0.7, 3.5, 17.5, and 100 kU/l), which are presumably manufactured and certified to specific standards. These calibrators are used by the instrument's built-in software to create a calibration curve against which patient samples are measured.

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