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The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 or CAPILLARYS ß1-S2" kits designed for serum proteins separation into 6 major fractions in alkaline buffer (pH 9.9). Identification of Monoclonal immunoglobulins is essential for the classification of monoclonal gammopathies by the class and type of involved immunoglobulins. "For In Vitro Diagnostic Use."

The CAPILLARYS system performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each sample is mixed with individual antisera that are specific against gamma (IgG), alpha (IgA) and mu (IgM) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains. The proteins fractions, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually by comparing the profile of the untreated sample with the individual profiles treated with the respective antisera. Monoclonal immunoglobulins are thus detected and identified.

This document does not contain the information required to populate all sections of the requested table and study description. It is a 510(k) clearance letter for the CAPILLARYS IMMUNOTYPING device, indicating substantial equivalence to a predicate device, but does not detail the specific acceptance criteria or the study data used to demonstrate performance.

Here's a breakdown of what can be extracted and what is missing:

Information Present:

• Device Name: CAPILLARYS IMMUNOTYPING, PN 2100
• Intended Use: Detection and characterization of monoclonal proteins (immunotyping) in human serum with the SEBIA CAPILLARYS System for capillary electrophoresis. It is used in conjunction with CAPILLARYS PROTEIN(E) 6 or CAPILLARYS ß1-S2 kits for serum protein separation.
• Mechanism: Automatic procedural sequences to obtain a protein profile for qualitative analysis. Samples are mixed with individual antisera (IgG, IgA, IgM heavy chains, kappa and lambda light chains). Proteins are separated in silica capillaries and detected by absorbance at 200 nm. Electrophoregrams are evaluated visually by comparing untreated and antisera-treated profiles to detect and identify monoclonal immunoglobulins.

Information NOT Present in the Provided Document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size of human reader improvement with AI vs. without AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• Sample size for the training set.
• How the ground truth for the training set was established.

Conclusion:

This document is a regulatory clearance letter. It confirms the FDA's determination of substantial equivalence for the device. However, it does not provide the detailed study results, acceptance criteria, or methodological specifics of the performance studies that would have been submitted to the FDA to support this clearance. Such details are typically found in the full 510(k) submission document, which is not provided here.

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