VENTANNA ANTI-CD3 PRIMARY ANTIBODY

K941505 · Ventana Medical Systems, Inc. · DEH · May 30, 1996 · Immunology

Device Facts

• Record ID: K941505
• Device Name: VENTANNA ANTI-CD3 PRIMARY ANTIBODY
• Applicant: Ventana Medical Systems, Inc.
• Product Code: DEH · Immunology
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

Ventana Medical Systems, Inc. developed Anti-CD3 (Clone UCHT-1) for use on the Ventana ES automated immunohistochemistry system.

Device Story

Anti-CD3 (Clone UCHT-1) reagent for immunohistochemistry; used on Ventana ES automated slide stainer. Input: frozen tissue samples (normal/pathologic). Process: automated staining of lymphoid cells. Output: stained slides evaluated by pathologist for staining intensity/background. Clinical use: identification of T-lymphocytes in tissue samples; aids in diagnosis of lymphoid-origin pathologies. Benefit: standardized, reproducible detection of T-cell markers.

Clinical Evidence

Bench testing using frozen normal and pathologic tissue samples. Staining intensity scored 0-4+. Sensitivity: 8 of 9 T-cell lymphomas stained. Specificity: appropriate staining of lymphoid origin cells, no staining of non-lymphoid cells. Reproducibility: inter-run (n=10) mean 4.00 ± 0.00; intra-run (n=10) mean 4.00 ± 0.00.

Technological Characteristics

Immunohistochemical reagent (Anti-CD3, Clone UCHT-1). Automated staining via Ventana ES system. Staining intensity scoring system (0-4+).

Indications for Use

Indicated for use on the Ventana ES automated immunohistochemistry system to detect cellular elements of lymphocytic origin in frozen tissue preparations.

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.

Reference Devices

• Antibodies detecting cellular elements of lymphocytic origin (Reinherz, E. L., and S. F. Schlossman, Cell 1980)

Submission Summary (Full Text)

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K941505 MAY 30 1996

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Ventana Medical Systems, Inc. developed Anti-CD3 (Clone UCHT-1) for use on the Ventana ES automated immunohistochemistry system. Ventana’s Anti-CD3 (Clone UHCT-1) is substantially equivalent to antibodies detecting cellular elements of lymphocytic origin as reported by Reinherz, E. L., and S. F. Schlossman. The differentiation and function of human T lymphocytes. *Cell*. 1980; Vol 19, pp. 821-827.

## Comparative Study

Supporting data for the equivalence statement is shown by the following study. Frozen preparations from normal and pathologic samples were tested using Ventana’s Anti-CD3 (Clone UCHT-1). 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 for specific staining intensity and background staining.

## Results

Staining occurred in the plasma membrane of cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.

Specificity of the antibody was shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. In addition, the specificity seen in this study agrees with the data published by Reinherz, E. L., and S. F. Schlossman, 1980.

The sensitivity of this antibody was shown by consistent staining of 8 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissue. As with any immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control which was run with each tissue gave negative results.

Staining intensity was scored on a scale of 0 - 4+. Inter-run reproducibility was determined based on samples of the same tissue on 10 different instrument runs with a mean staining intensity and standard deviation of 4.00 ± 0.00. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run. The mean staining intensity and standard deviation of the ten slides was 4.00 ± 0.00.