(1040 days)
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No
The summary describes an antibody for immunohistochemistry used on an automated staining system, with performance evaluated by a pathologist. There is no mention of AI, ML, or image processing that would indicate the use of such technology.
No.
The device is an antibody used for diagnostic purposes in immunohistochemistry, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "for use on the Ventana ES automated immunohistochemistry system," which is used in pathology labs to detect specific antigens in tissue samples. This type of use strongly indicates a diagnostic purpose. Additionally, the "Summary of Performance Studies" describes how the device was evaluated for its ability to appropriately stain cells of lymphoid origin and T cell lymphomas, aligning with a diagnostic function.
No
The device description and performance studies clearly indicate this is an antibody (Ventana Anti-CD8) used on an automated immunohistochemistry system (Ventana ES), which are physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for use on an automated immunohistochemistry system. Immunohistochemistry is a laboratory technique used to detect specific antigens in tissue samples, which is a form of in vitro testing.
- Device Description: The description confirms it's an antibody used in conjunction with an automated system, further supporting its use in a laboratory setting for testing biological samples.
- Anatomical Site: The listed anatomical sites (tonsil, thymus, blood, lymphomas) are all biological samples that would be tested in vitro.
- Intended User: The intended user is a "qualified pathologist," who works in a laboratory setting interpreting diagnostic tests.
- Performance Studies: The description of performance studies involves testing "normal and pathologic samples" and evaluating "staining intensity and background staining," which are all activities performed in a laboratory for diagnostic purposes.
- Key Metrics: The mention of "Sensitivity" as a key metric is common for diagnostic tests.
All these factors point to the device being used to perform tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ventana Medical Systems. Inc. developed Ventana Anti-CD8 (Clone SFC121Thy2D3) for use on the Ventana ES automated immunohistochemistry system.
Product codes
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Device Description
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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 Ventana Anti-CD8 (Clone SFCI21Thv2D3). 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.
Summary of Performance Studies
Inter-run reproducibility was determined by using the same positive control (frozen tonsil) on each of 10 different instrument runs. All ten slides stained positively for CD8 antigen.
Intra-run reproducibility was determined based on ten same frozen tonsil tissue within one run. All ten slides stained positively for CD8 antigen.
Key Metrics
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. and Deegan2.
The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissues (9 of 9 blood smears, 4 of 4 peripheral blood lymphocyte cytospins, 4 of 4 thymus tissues and 10 of 10 tonsil tissues).
Predicate Device(s)
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Reference Device(s)
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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
KQ41784
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 Ventana Anti-CD8 (Clone SFC121Thy2D3) for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-CD8 (Clone SFCI21Thy2D3) is substantially equivalent to antibodies detecting cellular elements of lymphocytic 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 Ventana Anti-CD8 (Clone SFCI21Thv2D3). 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 on the surface of lymbhoid 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. and Deegan2.
The reactivity of this antibody was shown by consistent staining of 9 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissues (9 of 9 blood smears, 4 of 4 peripheral blood lymphocyte cytospins, 4 of 4 thymus tissues and 10 of 10 tonsil tissues). As with any 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 was determined by using the same positive control (frozen tonsil) on each of 10 different instrument runs. All ten slides stained positively for CD8 antigen.
Intra-run reproducibility was determined based on ten same frozen tonsil tissue within one run. All ten slides stained positively for CD8 antigen.
'Reinherz EL, Hussey RE, Fitzgerald K, Snow P, Terhorst C and Schlossman SF: Antibody directed at a surface structure inhibits cytolytic but not suppressor function of human T lymphocytes. Nature 1981, 294:168-170,
"Deegan Michael J: Membrane antigen analysis in the diagnosis of lymphomas. Arch Pathol Lab Med 1989, 113:606-618.
Revised on December 10, 1996