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AlaSTAT Microplate Allergen-Specific IgE is a kinetic enzyme immunometric assay system designed for the measurement of allergen-specific IgE in serum. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

The AlaSTAT Microplate Mixed Allergen Panels are clinical devices used for detection of IgE antibodies to specific allergens in serum.

The provided document describes the safety and effectiveness of the AlaSTAT Microplate Mixed Allergen Panels. The study compares the performance of the new mixed allergen panels against the existing AlaSTAT Microplate Allergen-Specific IgE System which serves as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the comparison to the predicate device. The goal is to show agreement, relative sensitivity, and relative specificity that suggests the new device is "as safe and effective" as the predicate. While explicit thresholds for "acceptance criteria" are not given as specific numerical targets independent of the predicate, the reported performance demonstrates high agreement, sensitivity, and specificity in comparison to the specific allergens.

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

The sample sizes for the test sets (patient samples) are as follows:

• Food Panel #5 (FP5M): N = 63
• Food Panel #6 (FP6M): N = 34
• Food Panel #7 (FP7M): N = 36
• Grass Panel #2 (GP2M): N = 39
• Grass Panel #3 (GP3M): N = 31
• Dust Panel #1 (HP1M): N = 32

The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

This information is not provided. The ground truth for the comparison is established by "Specific Allergens" using the predicate AlaSTAT Microplate Allergen-Specific IgE System, not by human experts.

4. Adjudication Method for the Test Set:

Not applicable. Ground truth is established by the predicate device's results for specific allergens, not by human adjudication of cases.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance equivalence of a diagnostic assay system, comparing a new panel formulation to an existing one, rather than evaluating the impact on human readers.

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

Yes, this study represents a standalone performance evaluation. The AlaSTAT Microplate Mixed Allergen Panels are in vitro diagnostic devices, and their performance is measured directly against the predicate device's results without human intervention in the interpretation of the device output itself. The output of the device (kU/L and Class number) would then be interpreted by clinicians, but the study focuses on the analytical performance of the assay.

7. Type of Ground Truth Used:

The ground truth used is the performance of specific allergen tests from the AlaSTAT Microplate Allergen-Specific IgE System (the predicate device). The mixed panels are compared to the results obtained from testing individual, specific allergens previously validated with the same technology.

8. Sample Size for the Training Set:

This information is not provided. The document describes a method comparison study for the new panels against an existing system, rather than a machine learning model that would require a separate training set.

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

Not applicable, as this is not a machine learning study involving a training set. The comparison is against an established predicate device.

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