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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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