VENTANA ANTI-S100 PRIMARY ANTIBODY

K941514 · Ventana Medical Systems, Inc. · DEH · Apr 25, 1997 · Immunology

Device Facts

• Record ID: K941514
• Device Name: VENTANA ANTI-S100 PRIMARY ANTIBODY
• Applicant: Ventana Medical Systems, Inc.
• Product Code: DEH · Immunology
• Decision Date: Apr 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K941514 · Apr 25, 1997	VENTANA ANTI-S100 PRIMARY ANTIBODY	Ventana Medical Systems, Inc.	Retrospective excess clinical tissue samples	Retrospective evaluation of staining performance (sensitivity) on normal and pathologic tissue samples (leiomyosarcomas, squamous cell carcinomas, breast carcinomas, carcinoid tumors, and melanomas) compared to published literature.	Retrospective; Clinical tissue samples; Immunohistochemistry; Sensitivity

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective evaluation of clinical tissue samples	Normal and pathologic tissues (leiomyosarcomas, squamous cell carcinomas, breast carcinomas, carcinoid tumors, and melanomas)	Published literature	Staining intensity and background staining

Indications for Use

Ventana Medical Systems, Inc. developed the Ventana Anti-S100 antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-S100 is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in diagnosis of anaplastic tumors.

Device Story

Ventana Anti-S100 (rabbit polyclonal) antibody; used on Ventana ES automated immunohistochemistry system. Input: paraffin-embedded tissue samples. Principle: immunohistochemical staining of S100 protein epitope. Output: stained tissue slides for microscopic examination by pathologist. Used in clinical pathology labs; operated by laboratory technicians. Staining intensity and pattern aid pathologists in identifying cell lineage and diagnosing anaplastic tumors. Benefit: provides standardized, reproducible immunohistochemical detection of S100 protein to support diagnostic accuracy.

Clinical Evidence

Bench testing only. Evaluated on paraffin-embedded normal and pathologic tissues (leiomyosarcomas, squamous cell carcinomas, breast carcinomas, carcinoid tumors, melanomas). Sensitivity: 80% for melanoma tissues. Reproducibility: Inter-run (16 runs) and intra-run (10 samples) testing showed consistent staining intensity and patterns. Specificity confirmed via pre-absorption with S100 protein, resulting in complete loss of staining.

Technological Characteristics

Rabbit polyclonal antibody; purified via ammonium sulphate fractionation, DEAE-Sephadex chromatography, and Sephadex G100 gel filtration. Formulated for use on Ventana ES automated slide stainer. Detection based on antigen-antibody interaction.

Indications for Use

Indicated for use as an aid in the diagnosis of anaplastic tumors by identifying cells of normal and abnormal lineage in tissue samples.

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

• Epithelial Membrane Antigen (EMA)

Submission Summary (Full Text)

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K941514
APR 25 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-S100 antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-S100 is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in diagnosis of anaplastic tumors. Epithelial Membrane Antigen (EMA) is such a stain.

## Antibody

Ventana Medical Systems’ Anti-S100 (rabbit polyclonal) contains rabbit antiserum directed against an epitope found on S100 protein. S100 used for immunization was purified by ammonium sulphate fractionation, DEAE-Sephadex chromatography and gel filtration on Sephadex G100. The antiserum was obtained from rabbits after repeated injections of S100 protein complexed to methylated bovine serum albumin in complete Freund’s adjuvant. To determine if positive staining was a consequence of the S100 antiserum-S100 antigen interaction, 50μg of S100 protein was mixed with a 1/200 dilution of S100 antiserum prior to immunostaining. Pre-absorption resulted in complete loss of staining of tissue sections.

## 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-S100. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included leiomyosarcomas, squamous cell carcinomas, breast carcinomas, carcinoid tumors and melanomas. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated for specific staining intensity and background staining.

## Results

Sensitivity of Ventana Anti-S100 was shown by the appropriate staining of nerve cells in normal tissues tested and staining of 80% of the melanoma tissues tested. This data compares favorably to published literature.

Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs. Staining intensity and pattern of staining was similar in all tissue slides evaluated. Intra-run reproducibility was determined based on ten samples of the same tissue within one run. The staining intensity and pattern of staining in the ten slides was similar in all slides.