VENTANA CEA PRIMARY ANTIBODY

K940242 · Ventana Medical Systems, Inc. · DFD · Dec 23, 1996 · Immunology

Device Facts

• Record ID: K940242
• Device Name: VENTANA CEA PRIMARY ANTIBODY
• Applicant: Ventana Medical Systems, Inc.
• Product Code: DFD · Immunology
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

Ventana Medical Systems, Inc. developed the Ventana CEA Primary Antibody for use on the Ventana ES automated slide staining system.

Device Story

Ventana CEA Primary Antibody (clone TF 3H8-1) is an immunohistochemical reagent used on the Ventana ES automated slide staining system. Input: paraffin-embedded tissue samples. Process: automated slide staining; antibody binds to specific antigens on epithelial cells. Output: stained tissue slides for microscopic examination. Used in clinical pathology laboratories; operated by laboratory technicians and pathologists. Pathologist evaluates staining intensity and background to identify epithelial cancers. Benefits: provides diagnostic information regarding tissue origin and malignancy status.

Clinical Evidence

Bench testing only. Comparative study of Ventana CEA vs. anti-human cytokeratin on normal and pathologic paraffin-embedded tissues. Sensitivity: 9/10 breast and 10/10 colon malignancies stained. Specificity: consistent with published literature (Verstijnen et al., 1986). Reproducibility: 16/16 inter-run and 10/10 intra-run consistency achieved.

Technological Characteristics

Immunohistochemical reagent (clone TF 3H8-1). Formulated for use on Ventana ES automated slide stainer. Principle: antigen-antibody binding for visualization of epithelial cells in paraffin-embedded tissue sections.

Indications for Use

Indicated for use as an immunohistochemical reagent to stain antigens on cells of epithelial origin in paraffin-embedded tissue preparations. Intended for use by qualified pathologists to aid in the identification of epithelial line cancers.

Regulatory Classification

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.

Predicate Devices

• anti-human cytokeratin (clone CAM 5.2)

Submission Summary (Full Text)

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K940242
DEC 23 1996

# 510(k) Summary of Safety and Effectiveness

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.

## Comparative Study

Supporting data for the equivalence statement is shown by the following study. Paraffin embedded preparations from normal and pathologic samples were tested using the Ventana CEA Primary Antibody and a commercially available anti-human cytokeratin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic and normal tissues were examined. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist on a blinded basis for specific staining intensity and background staining.

## Results

Staining with both antibodies occurred in the epithelial cells of normal breast, anexal glandular cells of skin, glandular cells of stomach, prostate and pancreas.

Cytokeratin stained brain, glandular cells of pituitary and tubular cells of kidney. CEA did not stain these tissues. Since the antigens are different, it would not be expected to have 100% concordance. There was however, no inappropriate staining of tissue by either of the antibodies.

When compared with the commercially available anti-human cytokeratin antibody, Ventana CEA Primary Antibody stained the same tissues 78% of the time for epithelial line cancers. Neither Ventana CEA Primary Antibody nor the commercially available cytokeratin antibody stained any of the non-epithelial or non-mesothelial type cancers.

Specificity of both antibodies was shown with appropriate staining of cells of epithelial origin and no staining of cells of endodermal origin. In addition, the specificity seen in this study agrees with the data published by (Verstijnen et al., Anticancer Research 6:97-104, 1986).

The sensitivity of this antibody was shown by consistent staining of 9 of 10 breast and 10 of 10 colon malignancies, and appropriate staining of normal epithelial tissue. As with any immunohistochemical reagent, the sensitivity is dependent on fixation, tissue processing, and slide preparation parameters.

The negative control which was run with each tissue gave negative results with one exception. In this case, the negative control gave the same score as the non-specific

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background (1+) which indicates that there was some interference due to the tissue and not the specific antibody.

Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs with equivalent staining in all 16 slides. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run with equivalent staining in all ten slides.