← Product Code [DEH](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH) · K941397 # ANTI-VIMENTIN PRIMARY ANTIBODY (K941397) _Ventana Medical Systems, Inc. · DEH · Feb 10, 1997 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH/K941397 ## Device Facts - **Applicant:** Ventana Medical Systems, Inc. - **Product Code:** [DEH](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH.md) - **Decision Date:** Feb 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5550 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use Ventana Anti-Vimentin (clone VIM 3B4) is intended for use on the Ventana ES automated immunohistochemistry system for the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors. ## Device Story Ventana Anti-Vimentin (clone VIM 3B4) primary antibody; used on Ventana ES automated immunohistochemistry system. Input: paraffin-embedded tissue samples (normal and pathologic). Process: automated immunohistochemical staining of tissue slides. Output: stained slides for microscopic examination by pathologist. Clinical use: aid in diagnosis of anaplastic tumors by identifying mesenchymal origin cells. Benefit: provides standardized, reproducible staining for diagnostic assessment of tumor lineage. ## Clinical Evidence Bench testing using paraffin-embedded tissue samples (n=20 melanomas, 8 sarcomas, 9 adenocarcinomas, 10 squamous cell carcinomas, 9 carcinoids). Primary endpoints: staining intensity and background staining compared to literature (Azumi and Battifora). Results: 20/20 melanomas and 8/8 sarcomas stained positive; adenocarcinomas, squamous cell carcinomas, and carcinoids showed negative results consistent with literature. Reproducibility: 100% equivalence across 16 inter-run and 10 intra-run tests. ## Technological Characteristics Primary antibody (clone VIM 3B4) for immunohistochemistry. Automated slide staining via Ventana ES system. Reagent-based detection of mesenchymal origin cells. ## 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. ## Reference Devices - Barwick, K.W. Intermediate Filaments and Keratin in Atlas of Diagnostic Immunohistopathology (1990) - Azumi N. and H. Battifora Am J. Clin Pathol. 1987; Vol 88 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 02/07/97 FRI 11:52 FAX 1 520 8872558 VENTANA MEDICAL SYSTEMS 001 K941397 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-Vimentin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Vimentin (clone VIM 3B4) 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 Ventana Anti-Vimentin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included breast carcinomas, melanomas, squamous cell carcinomas and leiomyosarcomas. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated on a blind basis for specific staining intensity and background staining. ## Results Sensitivity of the antibodies was shown by appropriate staining of cells of mesenchymal origin and agreement with reported literature (Barwick, K.W. Intermediate Filaments and Keratin in Atlas of Diagnostic Immunohistopathology. Ed. L.D. True. 1990. J.B. Lippincott Co., Philadelphia. Azumi N. and H. Battifora Am J. Clin Pathol. 1987; Vol 88, pg 286-296.). In the Ventana study, 20 of 20 melanomas and 8 of 8 sarcomas stained positively compared to 16 of 18 melanomas and 17 of 20 sarcomas reported by Azumi and Battifora. Adenocarcioma (0/9), Squamous cell carcinoma (0/10), and Carcinoid (0/9) compared favorably to positive test results reported by Azumi and Battifora, 15/147, 1/7, and 1/10, respectively. Inter-run reproducibility, based on samples of the same tissue on 16 different instrument runs. Staining was equivalent for all slides. Intra-run reproducibility, based on 10 samples of the same tissue within one run. Staining was equivalent for all slides. --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH/K941397](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEH/K941397) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com