Who is the manufacturer of VENTANA ANTI-S100 PRIMARY ANTIBODY?

Ventana Medical Systems, Inc. filed the 510(k) submission for VENTANA ANTI-S100 PRIMARY ANTIBODY (K941514).

What is the FDA product code for VENTANA ANTI-S100 PRIMARY ANTIBODY?

DEH. It is classified under 21 CFR 866.5550 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for VENTANA ANTI-S100 PRIMARY ANTIBODY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VENTANA ANTI-S100 PRIMARY ANTIBODY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VENTANA ANTI-S100 PRIMARY ANTIBODY

Q: What are the predicate devices for VENTANA ANTI-S100 PRIMARY ANTIBODY?

Epithelial Membrane Antigen (EMA).

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

Intended 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)

Related Devices

K941397 — ANTI-VIMENTIN PRIMARY ANTIBODY · Ventana Medical Systems, Inc. · Feb 10, 1997
K941173 — ANTI-KERATIN-HMW PRIMARY ANTI-BODY · Ventana Medical Systems, Inc. · Mar 22, 1996
K941505 — VENTANNA ANTI-CD3 PRIMARY ANTIBODY · Ventana Medical Systems, Inc. · May 30, 1996
K935161 — KERATIN PRIMARY ANTIBODY · Ventana Medical Systems, Inc. · Mar 22, 1996
K940242 — VENTANA CEA PRIMARY ANTIBODY · Ventana Medical Systems, Inc. · Dec 23, 1996

Submission Summary (Full Text)

{0} 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.