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UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the 1. measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.
2. UniCAP 100 is a fully integrated and automated instrument including software for immunodiagnostic testing. UniCAP 100 is a user friendly instrument designed to handle all steps from sample and reagent handling to processing of results.
3. UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 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 or network server.
4. Pharmacia Specific IgE Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE and Pharmacia CAP System™ RAST® RIA/FEIA.
5. Pharmacia Specific IgE Negative Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE, Pharmacia CAP System™, RAST® RIA/FEIA and Phadebas RAST® RIA/FEIA and Phadebas RAST®/Phadezym®.

UniCAP is a fully integrated and automated system for the determinantion of specific IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP reagents, in this submission reagents for the measurement of allergen specific IgE; UniCAP RM External Software; and Pharmacia Specific IgE positive and negative Controls.

The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 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 UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Specific IgE Conjugate is introduced.

Here's an analysis of the provided text regarding the UniCAP 100 device and its acceptance criteria, structured according to your request:

K962274: UniCAP 100 Specific IgE Assay and Instrument

This submission describes the UniCAP 100 system, an automated in-vitro diagnostic system for the determination of specific IgE in human serum or plasma. It seeks to demonstrate substantial equivalence to the previously cleared Pharmacia CAP System.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the comparison study's objectives. While explicit numerical acceptance criteria (e.g., "must be greater than X%") are not stated as such, the reported performance serves as the basis for demonstrating substantial equivalence.

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

• Sample Size: More than 7,000 patient samples.
• Data Provenance: Not explicitly stated regarding country of origin. The study is a retrospective comparison as it uses existing patient samples to compare the performance of the new device (UniCAP 100) against an already established device (Pharmacia CAP System).

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

This information is not provided in the document. The "ground truth" in this context is established by the results from the predicate device (Pharmacia CAP System RAST FEIA), not by a panel of human experts interpreting the results.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the comparison is between two automated systems, there is no explicit adjudication method involving human experts. The comparison relies on the numerical outputs and classification of both systems.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated in-vitro diagnostic system for specific IgE measurements, not an AI-assisted diagnostic tool for image interpretation or similar tasks that would typically involve human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

Yes, a standalone performance evaluation was implicitly done. The entire comparison study assesses the UniCAP 100 system (instrument and reagents) as a standalone automated system (algorithm only, without human intervention in the result generation process) against another standalone automated system. The reported percentages are for the device itself.

7. The Type of Ground Truth Used

The "ground truth" in this comparison study is the results obtained from the predicate device, the Pharmacia CAP System RAST FEIA. The UniCAP 100's performance is measured by its agreement with the existing, cleared system, establishing substantial equivalence rather than absolute biological truth (e.g., pathology or long-term outcomes).

8. The Sample Size for the Training Set

The document does not specify a separate training set. The descriptions focus on the comparison study performed with "more than 7,000 patient samples." It's possible that the "training" (e.g., calibration and optimization) of the UniCAP 100 was done internally by the manufacturer prior to this comparison study, but details about such a training set are not included in this summary.

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

Since a dedicated training set is not explicitly described, the method for establishing its "ground truth" is not provided. If an internal development/optimization phase occurred, it would likely have also relied on comparison to established methods or clinical samples, but this is speculative given the provided text.

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