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DPC's IMMULITE® Cat/Dog/Mite-Specific IgE kits are clinical use devices intended for use with the IMMULITE Automated Immunoassay Analyzer to measure circulating levels of IgE antibodies specific to Cat Epithelium, Dog Dander and Dematophagoides pteronyssinus in serum. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE Cat/Dog/Mite-Specific IgE kits are solid-phase, two-site chemiluminescent enzyme immunometric assays for use with the IMMULITE Automated Analyzer.

Here's a breakdown of the acceptance criteria and study details for the IMMULITE® Cat/Dog/Mite-Specific IgE devices, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly established by the observed performance of the predicate device (AlaSTAT® Microplate Specific IgE) and the comparison to it. The study aimed to demonstrate "Performance Equivalence" through "Method Comparison."

Note: The acceptance criteria are "implied" because the document states the goal is "Performance Equivalence" to the predicate device. The presented results serve as the evidence that this equivalence was met to the satisfaction of the FDA.

2. Sample Size and Data Provenance

• Sample Sizes:
  • Cat-Specific IgE: 72 patient samples
  • Dog-Specific IgE: 72 patient samples
  • Mite-Specific IgE: 61 patient samples
• Data Provenance: Not explicitly stated, but given it's a submission to the US FDA by Diagnostic Products Corporation (Los Angeles, California), it's likely the samples were collected in the United States. The study is retrospective as it involves evaluating existing patient samples against a comparator method.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study does not involve human experts establishing a ground truth for a diagnostic interpretation in the traditional sense (e.g., radiologists reviewing images). Instead, it's a method comparison study where the "ground truth" is established by a legally marketed predicate device (AlaSTAT Microplate Specific IgE).

4. Adjudication Method

Not applicable, as this is a method comparison study against a predicate device, not a human reader study requiring adjudication.

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

Not applicable. This is a comparison between two in vitro diagnostic (IVD) assays, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, this study represents a standalone performance evaluation. The IMMULITE device, an automated immunoassay analyzer, is being evaluated independently against another in vitro diagnostic test (the AlaSTAT Microplate Specific IgE procedure). There is no human-in-the-loop component being assessed as part of the device's diagnostic output.

7. Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the predicate device, the DPC's AlaSTAT® Microplate Specific IgE for Cat/Dog/Mite (K911511, K954566). The study is a method comparison against a legally marketed and accepted assay.

8. Sample Size for the Training Set

Not applicable. This document describes a clinical performance evaluation (test set) for device clearance, not the development or training of an algorithm/AI system. Immunoassay devices like the IMMULITE are not "trained" in the same way as AI algorithms; their performance is determined by the biochemical properties of the reagents and the instrument's design.

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

Not applicable, as there is no "training set" for an AI algorithm in this context.

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