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The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE® Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.

Sheep antibodies to human IgG subclasses with the four subclasses of human IgG immunoglobulins, forming immuno-precipitates. This reaction consequently causes changes in the intensity of scattered light at a rate that increases gradually at first, then rapidly and finally proceeds through a peak rate of change (peak rate value) for the component being analyzed.

The provided text is a 510(k) summary for a medical device (Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit) and correspondence from the FDA confirming substantial equivalence. This document type does not typically contain detailed study data, acceptance criteria, or performance metrics in the format requested.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel effectiveness study results with specific acceptance criteria and performance data. It describes the device, its intended use, and identifies a predicate device. It does not include information typically found in a clinical study report or a validation study.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. This information would typically be found in accompanying technical documentation or detailed study reports, which are not part of this 510(k) summary document.

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