(883 days)
Not Found
Not Found
No
The device is an antibody used in an automated immunohistochemistry system and its performance is evaluated by a pathologist. There is no mention of AI/ML in the description, performance studies, or key metrics.
No
The device is an antibody used for in vitro diagnostic purposes to detect cellular elements, not to treat a condition.
Yes
The device, Ventana Anti-CD5 (clone L17F12/Leu-1), is used on the Ventana ES automated immunohistochemistry system to detect cellular elements, specifically for evaluating lymphoma specimens and normal cellular elements of lymphoid origin, indicating its use in identifying and characterizing disease states. The "Intended Use / Indications for Use" states it's for use in an automated immunohistochemistry system, and the performance studies describe its use in testing normal and pathologic samples, further supporting its role in diagnosis.
No
The device description clearly states it is an antibody for use on an automated immunohistochemistry system, indicating it is a biological reagent and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use on an automated immunohistochemistry system. Immunohistochemistry is a technique used to detect specific antigens in tissue samples, which is a common practice in diagnostic pathology.
- Device Description: It's described as an antibody detecting cellular elements of lymphocytic origin. Antibodies used for detecting specific markers in biological samples are a core component of many IVD tests.
- Anatomical Site: It's used on normal and pathologic samples, including tissues, cytospins, and blood smears. These are all biological specimens typically analyzed in a clinical laboratory setting for diagnostic purposes.
- Intended User: The intended user is a "Qualified independent pathologist." Pathologists are medical professionals who diagnose diseases based on the examination of tissues and body fluids, often using IVD devices.
- Performance Studies: The document describes performance studies involving testing on normal and pathologic samples (lymphoma specimens, tonsil, thymus, blood). These studies are conducted to demonstrate the device's ability to accurately detect the target antigen in relevant clinical samples, which is a requirement for IVD devices.
The information provided strongly indicates that this device is designed to be used in a laboratory setting to perform tests on biological samples for the purpose of aiding in the diagnosis of disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
Ventana Medical Systems, Inc. developed the Ventana Anti-CD5 (clone L17F12/Leu-1) for use on the Ventana ES automated immunohistochemistry system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Frozen tissue preparations from normal and pathologic samples as well as cytospins and blood smears from normal subjects were tested using the Ventana Anti-CD5 (clone L17F12/Leu-1). Samples were obtained from excess tissues and specimens obtained for reasons other than the present study. Pathologic tissues examined were lymphoma specimens. Normal specimens examined were tonsil, thymus, cytospins and blood smears.
Summary of Performance Studies
Comparative Study:
Frozen tissue preparations from normal and pathologic samples as well as cytospins and blood smears from normal subjects were tested. Pathologic tissues examined were lymphoma specimens. Normal specimens examined were tonsil, thymus, cytospins and blood smears. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination and evaluated by a qualified independent pathologist for specific staining intensity and background staining. These results were compared to literature reports.
Results:
L17F12/Leu-1 detects an antigen present on 95-100% of human peripheral T lymphocytes, the majority of thymocytes and acute lymphocytic leukemia T cells' and less than 5% of peripheral blood B lymphocytes, 54-87% of T cell lymphomas, most all B cell chronic lymphocytic leukemia and centrocytic (mantle cell) lymphomas.
In Ventana's testing, the antibody showed appropriate staining of normal cells of lymphoid origin from normal tonsil, thymus and blood. For example, in tonsil a majority of lymphocytes in the interfollicular areas (T cell predominant) stain positive. Scattered cells in the mantle zone (B cell predominant), germinal centers (dendritic rich), subepithelial and perivascular regions also stain positively. Staining of cells of nonlymphoid origin was not undertaken nor reported. There was no inappropriate staining of the specimens in this study. In addition, this study agrees with the data published by Engleman, et.al. and Chan, et.al.
The reactivity of this antibody was shown by consistent staining of lymphoid cells in 8 of 9 T cell lymphomas, 0 of 11 B cell lymphomas and 0 of 11 Hodgkins lymphomas. As with any immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control antibody which was run with each tissue produced negative results.
Inter-run reproducibility:
Determined based on samples of the same frozen tonsil tissue on ten different instrument runs using Ventana DAB Detection Kit. All ten slides stained positively for CD5 antigen.
Intra-run reproducibility:
Determined based on ten samples of the same frozen tonsil tissue within one run. All ten slides stained positively for CD5 antigen.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
K941782 SEP 10 1996
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-CD5 (clone L17F12/Leu-1) for use on the Ventana ES automated immunohistochemistry system. Ventana's Anti-CD5 (clone L17F12/Leu-1) is substantially equivalent to antibodies detecting cellular elements of lymphocytic origin as reported by E. G. Engleman et. al. and J. K. C. Chan et. al.2
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Frozen tissue preparations from normal and pathologic samples as well as cytospins and blood smears from normal subjects were tested using the Ventana Anti-CD5 (clone L17F12/Leu-1). Samples were obtained from excess tissues and specimens obtained for reasons other than the present study. Pathologic tissues examined were lymphoma specimens. Normal specimens examined were tonsil, thymus, cytospins and blood smears. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination and evaluated by a qualified independent pathologist for specific staining intensity and background staining. These results were compared to literature reports.
Results
L17F12/Leu-1 detects an antigen present on 95-100% of human peripheral T lymphocytes, the majority of thymocytes and acute lymphocytic leukemia T cells' and less than 5% of peripheral blood B lymphocytes, 54-87% of T cell lymphomas, most all B cell chronic lymphocytic leukemia and centrocytic (mantle cell) lymphomas2.3.
In Ventana's testing, the antibody showed appropriate staining of normal cells of lymphoid origin from normal tonsil, thymus and blood. For example, in tonsil a majority of lymphocytes in the interfollicular areas (T cell predominant) stain positive. Scattered cells in the mantle zone (B cell predominant), germinal centers (dendritic rich), subepithelial and perivascular regions also stain positively. Staining of cells of nonlymphoid origin was not undertaken nor reported. There was no inappropriate staining of the specimens in this study. In addition, this study agrees with the data published by Engleman, et.al.1 and Chan, et.al. 3
The reactivity of this antibody was shown by consistent staining of lymphoid cells in 8 of 9 T cell lymphomas, 0 of 11 B cell lymphomas and 0 of 11 Hodgkins lymphomas. As with any immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control antibody which was run with each tissue produced negative results.
Inter-run reproducibility was determined based on samples of the same frozen tonsil tissue on ten different instrument runs using Ventana DAB Detection Kit. All ten slides stained positively for CD5 antigen.
Intra-run reproducibility was determined based on ten samples of the same frozen tonsil tissue within one run. All ten slides stained positively for CD5 antigen.
1
'Engleman EG, Warnke R, Fox RI, Dilley J, Benike CJ and Levy R: Studies of a human T lymphocyte antigen recognized by a monoclonal antibody. Proc Natl Acad Sci, USA 1981, 78:1791-1795.
3Chan JKC, Ng CS and Hui PK: A simple guide to the terminology and application of leucocyte monoclonal antibodies. Histopathology 1988, 12:461-480.
3Zukerberg LR, Medeiros LJL, Ferry JA, Harris NL. Diffuse low-grade B cell lymphomas. Four clinically distinct subtypes defined by a combination of morphologic and immunophenotypic features. Am J Clin Path 1993; 100:373-385.