VENTANNA ANTI-DESMIN PRIMARY ANTIBODY

K941516 · Ventana Medical Systems, Inc. · DEH · Feb 10, 1997 · Immunology

Device Facts

• Record ID: K941516
• Device Name: VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
• Applicant: Ventana Medical Systems, Inc.
• Product Code: DEH · Immunology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

Ventana Anti-Desmin Primary Antibody for use on the Ventana ES automated immunohistochemistry system.

Device Story

Ventana Anti-Desmin Primary Antibody (clone DE-R-11) is an immunohistochemical reagent for use on the Ventana ES automated slide stainer. It identifies cells of myocytic origin in paraffin-embedded tissue samples. The device stains muscle cells in normal tissues (e.g., skin, intestine, cardiac muscle) and myocytic sarcomas. Used in clinical pathology laboratories; operated by trained laboratory personnel. Pathologists evaluate stained slides for specific staining intensity and background. Results aid in the diagnosis of anaplastic tumors by confirming or excluding myocytic lineage.

Clinical Evidence

Bench testing only. Study compared Ventana Anti-Desmin staining on normal and pathologic paraffin-embedded tissues against published literature (Jones et al, 1990). Specificity confirmed by staining myocytic origin cells and absence of staining in non-muscle cells. Sensitivity demonstrated by consistent staining of smooth/striated muscle and myocytic sarcomas. Reproducibility assessed via inter-run (11 runs) and intra-run (10 samples) testing, showing equivalent staining intensity.

Technological Characteristics

Immunohistochemical reagent (clone DE-R-11). Designed for use on Ventana ES automated slide stainer. Principle: antibody-antigen binding for tissue staining. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as an immunohistochemical stain to identify cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.

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

• Jones et al, 1990, Journal of Pathology, 162:29-33

Submission Summary (Full Text)

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02/07/97 FRI 11:53 FAX [phone]
VENTANA MEDICAL SYSTEMS
003
K941516
FEB 10 1997

# 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 the Ventana Anti-Desmin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Desmin Primary Antibody (clone DE-R-11) is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.

## 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 Anti-Desmin Primary Antibody and compared to published results (Jones et al, 1990, Journal of Pathology, 162:29-33). Samples were obtained from excess tissues obtained for reasons other than the present study. 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

Specificity of the antibody was shown by appropriate staining of cells of myocytic origin and no staining of cells of non-muscle origin. Staining occurred in the muscle cells of normal skin, small intestine, stomach, prostate, tonsil, esophagus, testes, pancreas, cardiac muscle, and kidney tissues. In addition, the specificity seen in this study agrees with the data published by Jones et al, 1990.

The sensitivity of this antibody was shown by consistent staining of normal smooth and striated muscle and appropriate staining of myocytic sarcomas. 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. When compared with literature results, Ventana Anti-Desmin Primary Antibody consistently stained the same type of line cancers.

Inter-run reproducibility was determined based on samples of the same intestinal tissue block on 11 different instrument runs. Staining was equivalent between all slides. Intra-run reproducibility was based on 10 samples of the same tissue within one run. The staining was

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equivalent between the ten slides.