(793 days)
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No
The description focuses on an antibody and an automated staining system, with no mention of AI/ML, image processing, or data-driven analysis of images or other data.
No.
The device is used for diagnostic purposes (immunohistochemistry) to aid pathologists in identifying T cell lymphomas, not for treating a condition.
Yes
The device is Anti-CD3 (Clone UCHT-1), an immunohistochemistry stain described as having performance studies (sensitivity, specificity, reproducibility) to detect T cell lymphomas in normal and pathologic samples, which indicates its use in aiding diagnosis by a pathologist.
No
The device is an antibody (Anti-CD3) used on an automated immunohistochemistry system (Ventana ES), which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It's an antibody (Anti-CD3) developed for use on an automated immunohistochemistry system. Immunohistochemistry is a laboratory technique used to detect specific antigens in tissue samples.
- Anatomical Site: It's used on tissue samples (normal tonsil, thymus, blood, T cell lymphomas).
- Intended User / Care Setting: It's used by a qualified pathologist, typically in a laboratory setting.
- Summary of Performance Studies: The studies describe testing on tissue samples to evaluate staining characteristics, sensitivity, and specificity.
- Key Metrics: Metrics like sensitivity and specificity are relevant to the performance of a diagnostic test.
All of these points indicate that the device is intended for use in the examination of specimens derived from the human body to provide information 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
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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
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Summary of Performance Studies
Comparative Study: Frozen preparations from normal and pathologic samples were tested using Ventana's Anti-CD3 (Clone UCHT-1). 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 cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study. Specificity 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 specificity seen in this study agrees with the data published by Reinherz, E. L., and S. F. Schlossman, 1980. The sensitivity of this antibody was shown by consistent staining of 8 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissue. 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. Staining intensity was scored on a scale of 0 - 4+. Inter-run reproducibility was determined based on samples of the same tissue on 10 different instrument runs with a mean staining intensity and standard deviation of 4.00 ± 0.00. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run. The mean staining intensity and standard deviation of the ten slides was 4.00 ± 0.00.
Key Metrics
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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
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 Anti-CD3 (Clone UCHT-1) for use on the Ventana ES automated immunohistochemistry system. Ventana's Anti-CD3 (Clone UHCT-1) is substantially equivalent to antibodies detecting cellular elements of lymphocytic origin as reported by Reinherz, E. L., and S. F. Schlossman. The differentiation and function of human T lymphocytes. Cell. 1980; Vol 19, pp. 821-827.
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's Anti-CD3 (Clone UCHT-1). 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 cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.
Specificity 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 specificity seen in this study agrees with the data published by Reinherz, E. L., and S. F. Schlossman, 1980.
The sensitivity of this antibody was shown by consistent staining of 8 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissue. 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.
Staining intensity was scored on a scale of 0 - 4+. Inter-run reproducibility was determined based on samples of the same tissue on 10 different instrument runs with a mean staining intensity and standard deviation of 4.00 ± 0.00. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run. The mean staining intensity and standard deviation of the ten slides was 4.00 ± 0.00.