VENTANA ANTI-CD4 PRIMARY ANTIBODY

K941604 · Ventana Medical Systems, Inc. · DEH · Feb 14, 1997 · Immunology

Device Facts

• Record ID: K941604
• Device Name: VENTANA ANTI-CD4 PRIMARY ANTIBODY
• Applicant: Ventana Medical Systems, Inc.
• Product Code: DEH · Immunology
• Decision Date: Feb 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

Ventana Medical Systems, Inc. developed the Ventana Anti-CD4 (clone SFCI12T4D11) for use on the Ventana ES automated immunohistochemistry system.

Device Story

Ventana Anti-CD4 (clone SFCI12T4D11) is a monoclonal antibody reagent for immunohistochemistry; used on Ventana ES automated slide stainer. Input: frozen tissue sections (tonsil, thymus, blood). Process: automated staining of CD4 antigen in plasma membranes of lymphoid cells. Output: visual staining pattern on slides evaluated by pathologist. Clinical context: diagnostic aid for identifying T-cell lymphomas and characterizing lymphoid tissue. Benefit: provides consistent, reproducible detection of CD4 antigen to assist in pathological diagnosis.

Clinical Evidence

Bench testing only. Study evaluated frozen preparations from normal (tonsil, thymus, blood) and pathologic (9 T-cell lymphomas) tissues. Primary endpoints: staining intensity and background staining. Results: 100% sensitivity in tested T-cell lymphomas (9/9) and normal lymphoid tissues (18/18). Negative controls were consistently negative. Inter-run and intra-run reproducibility confirmed via 10 consecutive runs and 10 samples per run, respectively, with 100% positive staining for CD4 antigen.

Technological Characteristics

Monoclonal antibody (clone SFCI12T4D11); immunohistochemical reagent; designed for use on Ventana ES automated slide stainer; utilizes automated staining process; reagent-based detection.

Indications for Use

Indicated for use on the Ventana ES automated immunohistochemistry system to detect CD4 antigen in frozen tissue preparations of normal and pathologic human lymphoid tissues.

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, et al., Proc. Natl. Acad. Sci. USA. 1979; 76:4061)

Submission Summary (Full Text)

{0}

K941604

510(k) Summary of Safety and Effectiveness

FEB 14 1997

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 the Ventana Anti-CD4 (clone SFCI12T4D11) for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-CD4 (Clone SFCI12T4D11) is substantially equivalent to antibodies detecting cellular elements of lymphocytic origin as reported by Reinherz, et al.¹

## Comparative Study

Supporting data for the equivalence statement is shown by the following study. Frozen preparations from normal and pathologic samples were tested using the Ventana Anti-CD4 (Clone SFCI12T4D11). 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 lymphoid cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.

Sensitivity 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 Ventana data in this study agrees with the data published by Reinherz et.al.¹

The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissues (4 of 4 peripheral blood lymphocyte cytospins, 4 of 4 thymus tissues and 10 of 10 tonsil tissues). 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.

Inter-run reproducibility the same positive control (tonsil) was used on each of 10 different instrument runs. All ten slides stained positively for CD4 antigen.

Intra-run reproducibility was determined based on ten samples of the same frozen tonsil tissue within one run. All ten slides stained positively for CD4 antigen.

¹Reinherz EL, Kung PC, Goldstein G, Schlossman SF. A separation of functional subsets of human T cells by a monoclonal antibody. Proc. Natl. Acad. Sci. USA. 1979; 76:4061.

Revised on December 6, 1996