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In vitro diagnostic reagent for the quantitative determination of IgE in human serum or plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

N Latex IgE mono Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of Immunoglobulin E (IgE) in human serum or plasma.

Acceptance Criteria and Device Performance Study for N Latex IgE mono Reagent

This report details the acceptance criteria for the N Latex IgE mono Reagent and the study demonstrating its performance.

1. Acceptance Criteria and Reported Device Performance

Note: The specific numerical targets for these criteria (e.g., minimum correlation coefficient, maximum precision percentages) are not explicitly stated in the provided document, but the reported performance values were deemed sufficient for substantial equivalence.

2. Sample Size and Data Provenance

• Test set sample size: 70 samples
• Data provenance: Not explicitly stated, but the samples ranged from 14 to 855 IU/ml, suggesting they were clinical samples with varying IgE levels. It is not specified if they were retrospective or prospective, nor their country of origin.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable as this is an in vitro diagnostic device and the 'ground truth' for comparison is a legally marketed predicate device's performance, not human expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

• Not applicable. The study involved a direct comparison of quantitative results between two assays, not interpretation requiring adjudication.

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

• Not applicable. This is an in vitro diagnostic device for quantitative IgE determination, not a device requiring human reader interpretation or assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was conducted. The N Latex IgE mono Reagent's performance was evaluated independently and then compared to the predicate device. The "correlation" and "precision" studies demonstrate the standalone performance characteristics of the new device relative to its predecessor.

7. Type of Ground Truth Used

• Legally Marketed Predicate Device Performance: The primary ground truth for the comparison study was the results obtained from the Dade Behring N Latex IgE kit (K890530), a legally marketed device that shares the same intended use.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" or its size. In the context of an IVD like this, methods are typically developed and validated rather than "trained" in the machine learning sense. The 70 samples mentioned were used for the correlation study, which serves as a validation set.

9. How Ground Truth for the Training Set was Established

• Not applicable, as a separate training set, in the machine learning sense, is not described. The validation and comparative studies relied on the predicate device's performance as the benchmark. Precision studies used control materials and human serum pools, whose "ground truth" concentrations would have been established through a reference method or assigned values. The document mentions consistency with NCCLS Guideline EP5-T2 for precision studies, implying established industry standards for ground truth in this context.

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