K941784 · Ventana Medical Systems, Inc. · DEH · Feb 14, 1997 · Immunology
Device Facts
Record ID
K941784
Device Name
VENTANA ANTI-CD8 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
Indications for Use
Ventana Medical Systems, Inc. developed Ventana Anti-CD8 (Clone SFC121Thy2D3) for use on the Ventana ES automated immunohistochemistry system.
Device Story
Ventana Anti-CD8 (Clone SFC121Thy2D3) is an immunohistochemical reagent; used on Ventana ES automated immunohistochemistry system. Input: frozen tissue preparations (normal/pathologic). Principle: antibody-antigen binding to detect CD8 surface markers on lymphoid cells. Output: specific staining intensity on slides. Used in clinical pathology labs; operated by laboratory personnel/pathologists. Pathologist evaluates staining intensity and background to identify lymphocytic origin of cells. Assists in diagnosis of lymphoid leukemias and lymphomas.
Clinical Evidence
Bench testing only. Study evaluated staining intensity and background on frozen normal and pathologic tissues (tonsil, thymus, blood). Sensitivity demonstrated by staining 9/9 T cell lymphomas and 27/27 normal lymphoid samples. Negative controls were negative. Inter-run and intra-run reproducibility confirmed via 10/10 positive staining on frozen tonsil tissue.
Technological Characteristics
Immunohistochemical reagent (Clone SFC121Thy2D3). Used with Ventana ES automated slide stainer. Principle: antibody-antigen binding. Form factor: liquid reagent for automated system.
Indications for Use
Indicated for use on the Ventana ES automated immunohistochemistry system to detect CD8 antigen in frozen preparations of normal and pathologic human tissue samples to aid in the identification of lymphocytic cellular elements.
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.)
Submission Summary (Full Text)
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K941784
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 Ventana Anti-CD8 (Clone SFC121Thy2D3) for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-CD8 (Clone SFC121Thy2D3) 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 Ventana Anti-CD8 (Clone SFC121Thy2D3). 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 on the surface 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 and Deegan².
The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissues (9 of 9 blood smears, 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 was determined by using the same positive control (frozen tonsil) on each of 10 different instrument runs. All ten slides stained positively for CD8 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 CD8 antigen.
¹Reinherz EL, Hussey RE, Fitzgerald K, Snow P, Terhorst C and Schlossman SF: Antibody directed at a surface structure inhibits cytolytic but not suppressor function of human T lymphocytes. Nature 1981, 294:168-170.
²Deegan Michael J: Membrane antigen analysis in the diagnosis of lymphoid leukemias and lymphomas. Arch Pathol Lab Med 1989, 113:606-618.
Revised on December 10, 1996
