← Product Code [DEH](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH) · K935161

# KERATIN PRIMARY ANTIBODY (K935161)

_Ventana Medical Systems, Inc. · DEH · Mar 22, 1996 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH/K935161

## Device Facts

- **Applicant:** Ventana Medical Systems, Inc.
- **Product Code:** [DEH](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH.md)
- **Decision Date:** Mar 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5550
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.

## Device Story

Ventana Keratin Primary Antibody (clone 5D3) is an immunohistochemical reagent for use on the Ventana 320 automated slide stainer. It detects cytokeratin in paraffin-embedded tissue sections. The device transforms tissue samples into stained slides via automated immunohistochemistry; staining intensity is evaluated by pathologists to identify epithelial-origin cells. Used in clinical pathology laboratories to aid cancer diagnosis. The output provides visual staining patterns; healthcare providers use these patterns to differentiate epithelial cancers from nonepithelial cancers, supporting clinical diagnostic decisions.

## Clinical Evidence

Bench testing comparing Ventana Keratin Primary Antibody to predicate on paraffin-embedded tissues. Sample set included 37 epithelial line cancers and various normal tissues. Results: 91% concordance in epithelial cancers; 30/37 sensitivity for subject vs 31/37 for predicate. Wilcoxon matched pairs analysis showed no significant difference in staining intensity (p > .01). Reproducibility (inter-run and intra-run) was identical (mean intensity 2.5 ± 0.00).

## Technological Characteristics

Immunohistochemical reagent (clone 5D3 antibody). Designed for use on Ventana 320 automated slide stainer. Staining principle: immunohistochemical detection of cytokeratin. Evaluated via staining intensity scoring (0-4+).

## Regulatory 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

- anti-human cytokeratin (clone CAM 5.2)

## Submission Summary (Full Text)

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MAR 22 1990
K935161

# 510(k) Summary of Safety and Effectiveness

Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system. Ventana Keratin Primary Antibody (clone 5D3) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2).

## 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 Ventana Keratin Primary Antibody and a commercially available anti-human cytokeratin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included colon carcinomas, breast carcinomas, prostatic carcinomas, adenocarcinoma, squamous cell carcinomas and nonepithelial cancers. Normal tissues examined were breast, ureter, thyroid, skin, small intestine, stomach, liver, adrenal, muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, kidney, connective tissue and salivary gland. Slides were processed on the Ventana 320 Automated Slide Stainer and prepared for examination, then evaluated on a blind basis for specific staining intensity and background staining.

## Results

When compared with a commercially available anti-human cytokeratin antibody, Ventana Keratin Primary Antibody stained the same tissues 91% of the time in epithelial line cancers. Neither Ventana Keratin Primary Antibody nor the commercially available antibody stained any of the nonepithelial type cancers. The staining patterns of the normal tissues were considered to be appropriate.

Staining intensity was scored on a scale of 0 - 4+. Non parametric analysis of the staining intensity results (Wilcoxon matched pairs) shows no difference in the performance of the two antibodies tested, even at the .01 level of significance.

Specificity of both antibodies was proven with appropriate staining of cells of epithelial origin and no staining of cells of mesodermal or endodermal origin. Sensitivity of keratin antibodies, based on comparison of 37 epithelial line cancers, showed that Ventana Keratin Primary Antibody stained 30 of 37 and the commercially available anti-human cytokeratin antibody stained 31 of 37.

Inter-run reproducibility, based on samples of the same tissue on 16 different instrument runs, and intra-run reproducibility, based on 10 samples of the same tissue within one run, were identical for both antibodies. The mean staining intensity and standard deviation of each antibody was $2.5 \pm 0.00$.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH/K935161](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH/K935161)

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