(1050 days)
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No
The summary describes an antibody used on an automated immunohistochemistry system, with performance evaluated by a pathologist. There is no mention of AI, ML, or image processing that would suggest the use of such technology.
No
The device is used for immunohistochemistry, which is a diagnostic tool, not a therapeutic intervention. It helps identify CD4 in tissues, aiding in diagnosis rather than treatment.
No
The document does not explicitly state that the device is intended for diagnosis. It describes the device's use in staining biological samples for evaluation by a qualified pathologist, which is a step in the diagnostic process but does not make the device itself a diagnostic device.
No
The device description explicitly states it is for use on the "Ventana ES automated immunohistochemistry system," which is a hardware system. The performance studies also describe processing slides on this system and evaluating staining, indicating a physical component is involved.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic). Here's why:
- Device Description: It's an antibody (Ventana Anti-CD4) developed for use on an automated immunohistochemistry system. Antibodies used in immunohistochemistry are typically used to identify specific markers in tissue samples.
- Anatomical Site: It's used on samples from normal tonsil, thymus, blood, T cell lymphomas, and peripheral blood lymphocyte cytospins. These are all biological samples taken from the human body.
- Intended User / Care Setting: A qualified pathologist. Pathologists are medical professionals who diagnose diseases by examining tissues and body fluids.
- Summary of Performance Studies: The studies describe testing the antibody on normal and pathologic tissue samples and evaluating the staining results. This is consistent with the validation of a diagnostic test.
- Key Metrics: Mentions "Sensitivity of the antibody," which is a common metric for evaluating the performance of diagnostic tests.
While the "Intended Use / Indications for Use" section is listed as "Not Found," the other information strongly suggests that this device is intended to be used in a laboratory setting to examine biological samples for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Ventana Medical Systems, Inc. developed the Ventana Anti-CD4 (clone SFCI12T4D11) for use on the Ventana ES automated immunohistochemistry system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Frozen preparations from normal and pathologic samples were tested using the Ventana Anti-CD4 (Clone SFCI12T4D11). Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic and normal tissues were examined. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist for specific staining intensity and background staining.
The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas. and appropriate staining of normal lymphoid tissues (4 of 4 peripheral blood lymphocyte cytospins. 4 of 4 thymus tissues and 10 of 10 tonsil tissues).
Inter-run reproducibility the same positive control (tonsil) was used on each of 10 different instrument runs.
Intra-run reproducibility was determined based on ten samples of the same frozen tonsil tissue within one run.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Study: Frozen preparations from normal and pathologic samples were tested using the Ventana Anti-CD4 (Clone SFCI12T4D11). Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic and normal tissues were examined. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist for specific staining intensity and background staining.
Results: Staining occurred in the plasma membrane of lymphoid cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study. Sensitivity of the antibody was shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. The Ventana data in this study agrees with the data published by Reinherz et al. The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas. and appropriate staining of normal lymphoid tissues (4 of 4 peripheral blood lymphocyte cytospins. 4 of 4 thymus tissues and 10 of 10 tonsil tissues). As with anv immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control which was run with each tissue gave negative results.
Inter-run reproducibility: the same positive control (tonsil) was used on each of 10 different instrument runs. All ten slides stained positively for CD4 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 CD4 antigen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity of the antibody was shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Summary of Safety and Effectiveness
FEB 1 4 1997
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-CD4 (clone SFCI12T4D11) for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-CD4 (Clone SFCI12T4D11) is substantially equivalent to antibodies detecting cellular elements of Ivmphocvtic origin as reported by Reinherz, et al.1
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Frozen preparations from normal and pathologic samples were tested using the Ventana Anti-CD4 (Clone SFCI12T4D11). Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic and normal tissues were examined. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist for specific staining intensity and background staining.
Results
Staining occurred in the plasma membrane of lymphoid cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.
Sensitivity of the antibody was shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. In addition, the Ventana data in this study agrees with the data published by Reinherz et al.1
The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas. and appropriate staining of normal lymphoid tissues (4 of 4 peripheral blood lymphocyte cytospins. 4 of 4 thymus tissues and 10 of 10 tonsil tissues). As with anv immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control which was run with each tissue gave negative results.
Inter-run reproducibility the same positive control (tonsil) was used on each of 10 different instrument runs. All ten slides stained positively for CD4 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 CD4 antigen.
'Reinherz EL, Kung PC, Goldstein G, Schlossman SF. A separation of functional subsets of human T cells by a monoclonal antibody. Proc. Natl. Acad. Sci. USA. 1979; 76:4061.
Revised on December 6, 1996