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For the quantitative in vitro determination of IgE in human serum and plasma on automated clinical chemistry analyzers. IgE determinations are used as an aid in the diagnosis of allergic diseases.

The Boehringer Mannheim Tina-quant ® IgE test is based on the principle of immunological agglutination with enhanced of the reaction by latex.

The provided text describes the Boehringer Mannheim Tina-quant® IgE Test, comparing it to a predicate device (Behring N IgE Test) to establish substantial equivalence. However, the document does not contain details about specific acceptance criteria and a study that proves the device meets those criteria in the format requested.

The text focuses on:

• Device Description and Intended Use: For quantitative in vitro determination of IgE in human serum and plasma as an aid in diagnosing allergic diseases.
• Comparison to Predicate Device: Highlighting similarities in intended use, indications, sample type, assay principle, and standardization, while noting differences in measurement approach, instrument, and reagent formulation.
• Regulatory Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document only states "Performance characteristics: The performance of the Boehringer Mannheim Tina-quant ® IgE Test is substantially equivalent to other products device (cont.) in commercial distribution intended for similar use." It does not provide specific performance metrics or acceptance criteria thresholds.
2. Sample size used for the test set and the data provenance: No information on test sets or their characteristics is given.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no mention of a diagnostic study with ground truth establishment.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable, as this is an in-vitro diagnostic device and such a study is not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a lab test, not an AI algorithm.
7. The type of ground truth used: Not applicable, no diagnostic study details are provided.
8. The sample size for the training set: Not applicable, no training set details are provided.
9. How the ground truth for the training set was established: Not applicable.

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