ANTI-KERATIN-HMW PRIMARY ANTI-BODY

K941173 · Ventana Medical Systems, Inc. · DEH · Mar 22, 1996 · Immunology

Device Facts

• Record ID: K941173
• Device Name: ANTI-KERATIN-HMW PRIMARY ANTI-BODY
• Applicant: Ventana Medical Systems, Inc.
• Product Code: DEH · Immunology
• Decision Date: Mar 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

Ventana Medical Systems, Inc. developed Ventana Anti-Keratin-AE1 Primary Antibody (Clone AE1) for use on the Ventana ES Automated Slide Stainer.

Device Story

Ventana Anti-Keratin-AE1 Primary Antibody (Clone AE1) is an immunohistochemical reagent used on the Ventana ES Automated Slide Stainer; processes paraffin-embedded tissue samples; detects cytokeratin antigens; provides staining patterns to identify epithelial cells; used by pathologists in clinical laboratories; results assist in differential diagnosis of carcinomas versus non-epithelial tumors; benefits include standardized automated staining and improved diagnostic accuracy for epithelial cancers.

Clinical Evidence

Bench testing only. Comparative study of 18 epithelial cancers using Clone AE1 versus 36 carcinomas using CAM 5.2. Evaluated staining intensity and background on normal and pathologic tissues (breast, skin, etc.). Inter-run (n=15) and intra-run (n=10) reproducibility studies demonstrated equivalent staining intensity using Ventana DAB detection kit.

Technological Characteristics

Immunohistochemical primary antibody (Clone AE1); liquid reagent format; designed for use with Ventana ES Automated Slide Stainer; utilizes DAB detection system; manual/automated slide processing workflow.

Indications for Use

Indicated for use as an immunohistochemical reagent for the detection of cytokeratin in paraffin-embedded tissue samples to aid in the identification of epithelial origin cells in pathologic tissues.

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

• anti-human cytokeratin (clone CAM 5.2)

Submission Summary (Full Text)

{0}

K941173
MAR 22 1994

# 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 Ventana Anti-Keratin-AE1 Primary Antibody (Clone AE1) for use on the Ventana ES Automated Slide Stainer. Ventana Anti-Keratin-AE1 Primary Antibody (Clone AE1) 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 literature and the following study. Paraffin embedded preparations from normal and pathologic samples were tested using Ventana Anti-Keratin-AE1 Primary Antibody. 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, carcinoids, and leiomyosarcomas. Normal tissues examined were breast, ureter, thyroid, skin, small intestine, stomach, liver, smooth muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, and kidney. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated for specific staining intensity and background staining. These results were compared to data generated using a commercially available keratin antibody CAM 5.2.

## Results

Specificity and sensitivity of both antibodies was shown by appropriate staining of cells of epithelial origin and no staining of cells of mesodermal or endodermal origin. The antigenic sites for the Clone AE1 antibody have a different mix of subfamilies than the antigens detected by CAM 5.2, but there is crossover staining between the two antibodies. In the present study Anti-Keratin-AE1 Primary Antibody (Clone AE1) stained positively in 18 of 18 epithelial cancers compared to Anti-Keratin Primary Antibody (Clone CAM 5.2) which stained positively with 31 of 36 carcinomas tested.

Inter-run reproducibility of staining was based on samples of the same tissue on 15 different instrument runs with Anti-Keratin Antibody Clone AE1 and Ventana DAB detection kit and intra-run reproducibility of staining was based on 10 samples of the same tissue within one run, with Anti-Keratin-AE1 Primary Antibody (Clone AE1) and Ventana DAB detection kit. All slides stained with equivalent staining intensity.