(875 days)
Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.
Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.
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Device: Ventana Keratin Primary Antibody (clone 5D3) for use on the Ventana 320 automated immunohistochemistry system.
Description of Acceptance Criteria and Study:
The primary acceptance criteria for the Ventana Keratin Primary Antibody (clone 5D3) is its substantial equivalence to a commercially available anti-human cytokeratin (clone CAM 5.2). This equivalence is demonstrated through a comparative study evaluating staining patterns, intensity, specificity, and sensitivity in various tissue samples.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Threshold (Implied) | Reported Device Performance |
|---|---|---|---|
| Equivalence to Comparator | Staining in Epithelial Cancers | ~100% agreement with comparator | 91% agreement with comparator in epithelial line cancers |
| Specificity (Non-Epithelial Cancers) | No staining in non-epithelial cancers | 0% staining | Neither antibody stained any non-epithelial type cancers |
| Normal Tissue Staining | Appropriate staining patterns | Qualitative assessment of appropriateness | Staining patterns of normal tissues considered appropriate |
| Staining Intensity | No statistically significant difference from comparator | p |
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).