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Ventana Medical Systems, Inc. developed the Ventana CEA Primary Antibody for use on the Ventana ES automated slide staining system. Ventana CEA Primary Antibody (clone TF 3H8-1) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2) in that they both stain antigens on cells of epithelial origin.
Here's an analysis of the provided text, focusing on acceptance criteria and the study details:
The provided text, K94034J, is a 510(k) Summary of Safety and Effectiveness for the Ventana CEA Primary Antibody. This document describes a comparative study to demonstrate substantial equivalence to a commercially available anti-human cytokeratin antibody.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format with specific thresholds. Instead, it focuses on demonstrating "substantially equivalent" performance to a predicate device in terms of staining patterns and specificity. The key performance indicators evaluated are:
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance (Ventana CEA Primary Antibody) |
|---|---|
| Staining Pattern Equivalency to Predicate (CAM 5.2) on Epithelial Tissues | Stained the same epithelial cells (normal breast, anexal glandular cells of skin, glandular cells of stomach, prostate, pancreas) as the predicate. |
| Specificity (No Inappropriate Staining) | No inappropriate staining of tissue observed. |
| Agreement with Predicate for Epithelial Line Cancers | Stained the same tissues as the predicate 78% of the time for epithelial line cancers. |
| Absence of Staining for Non-Epithelial/Non-Mesothelial Cancers | Did not stain any non-epithelial or non-mesothelial type cancers (same as predicate). |
| Appropriate Staining of Cells of Epithelial Origin | Showed appropriate staining of cells of epithelial origin. |
| No Staining of Cells of Endodermal Origin | Showed no staining of cells of endodermal origin. |
| Sensitivity for Known Positive Tissues | Consistent staining of 9 of 10 breast malignancies and 10 of 10 colon malignancies. Appropriate staining of normal epithelial tissue. |
| Negative Control Performance | Negative results observed with negative controls, with one exception attributed to tissue interference (1+ background). |
| Inter-run Reproducibility | Equivalent staining across 16 different instrument runs using samples of the same tissue. |
| Intra-run Reproducibility | Equivalent staining for 10 samples of the same tissue within one run. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size:
- "Paraffin embedded preparations from normal and pathologic samples" were used. The exact number of samples is not specified, but it encompassed various normal tissues (breast, skin, stomach, prostate, pancreas, brain, pituitary, kidney) and pathologic samples (epithelial line cancers, breast malignancies (10 cases), colon malignancies (10 cases), non-epithelial/non-mesothelial cancers).
- For reproducibility: 16 samples of the same tissue for inter-run; 10 samples of the same tissue for intra-run.
- Data Provenance: "Samples were obtained from excess tissues obtained for reasons other than the present study." This indicates a retrospective collection of samples, likely from a pathology archive. The country of origin is not specified.
- Sample Size:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One ("a qualified pathologist").
- Qualifications of Experts: Desc
§ 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).