(1069 days)
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No
The summary describes an antibody and an automated slide staining system, with performance evaluated by a pathologist. There is no mention of AI, ML, image processing, or any computational analysis of images or data that would suggest the use of AI/ML.
No
The device is described as a primary antibody used for staining cells on an automated slide staining system, with its performance evaluated by a pathologist to identify epithelial cells in tissue samples. This indicates a diagnostic rather than therapeutic function.
Yes
Explanation: The device is an "antibody for use on an automated slide staining system" used to "stain antigens on cells of epithelial origin" in "paraffin embedded preparations from normal and pathologic samples." The performance studies evaluate its ability to stain "epithelial line cancers" and "malignancies," and the slides are "evaluated by a qualified pathologist." This indicates its role in identifying and characterizing disease, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "Primary Antibody" for use on an "automated slide staining system," indicating it is a physical reagent and part of a hardware system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It's a "Primary Antibody" used on an "automated slide staining system." Antibodies used for staining tissue samples are a common component of IVD tests.
- Intended User: A "qualified pathologist" is the intended user. Pathologists are medical professionals who diagnose diseases based on laboratory tests, including those using stained tissue samples.
- Performance Studies: The document describes a "Comparative Study" where the Ventana CEA Primary Antibody was compared to a commercially available antibody. The study evaluated "specific staining intensity and background staining" and reported metrics like "Sensitivity," "Specificity," "Inter-run reproducibility," and "Intra-run reproducibility." These are all standard performance metrics for IVD devices used in diagnostic testing.
- Anatomical Site: The antibody is used to stain various human tissues (breast, skin, stomach, prostate, pancreas, brain, pituitary, kidney). This indicates it's used to analyze human biological samples.
While the "Intended Use / Indications for Use" section is listed as "Not Found," the combination of the device type, intended user, performance study details, and the analysis of human tissue samples strongly indicates that this device is intended for in vitro diagnostic use. It's a reagent used in a laboratory setting to aid in the diagnosis of diseases by staining specific antigens in tissue samples.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Ventana Medical Systems, Inc. developed the Ventana CEA Primary Antibody for use on the Ventana ES automated slide staining system. Ventana CEA Primary Antibody (clone TF 3H8-1) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2) in that they both stain antigens on cells of epithelial origin.
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
Supporting data for the equivalence statement is shown by the following study. Paraffin embedded preparations from normal and pathologic samples were tested using the Ventana CEA Primary Antibody and a commercially available anti-human cytokeratin. 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 on a blinded basis for specific staining intensity and background staining.
Summary of Performance Studies
Comparative Study:
Paraffin embedded preparations from normal and pathologic samples were tested using the Ventana CEA Primary Antibody and a commercially available anti-human cytokeratin. 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 on a blinded basis for specific staining intensity and background staining.
Results:
Staining with both antibodies occurred in the epithelial cells of normal breast, anexal glandular cells of skin, glandular cells of stomach, prostate and pancreas.
Cytokeratin stained brain, glandular cells of pituitary and tubular cells of kidney. CEA did not stain these tissues. Since the antigens are different, it would not be expected to have 100% concordance. There was however, no inappropriate staining of tissue by either of the antibodies.
When compared with the commercially available anti-human cytokeratin antibody, Ventana CEA Primary Antibody stained the same tissues 78% of the time for enithelial line cancers. Neither Ventana CEA Primary Antibody nor the commercially available cytokeratin antibody stained any of the non-epithelial or non-mesothelial type cancers.
Specificity of both antibodies was shown with appropriate staining of cells of enithelial origin and no staining of cells of endodermal origin. In addition, the specificity seen in this study agrees with the data published by (Verstijnen et al., Anticancer Research 6:97-104. 1986).
The sensitivity of this antibody was shown by consistent staining of 9 of 10 breast and 10 of 10 colon malignancies, and appropriate staining of normal epithelial tissue. As with any immunohistochemical reagent, the sensitivity is dependent on fixation, tissue processing, and slide preparation parameters.
The negative control which was run with each tissue gave negative results with one exception. In this case, the negative control gave the same score as the non-specific background (1+) which indicates that there was some inteference due to the tissue and not the specific antibody.
Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs with equivalent staining in all 16 slides. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run with equivalent staining in all ten slides.
Key Metrics
Specificity: Staining with both antibodies occurred in the epithelial cells of normal breast, anexal glandular cells of skin, glandular cells of stomach, prostate and pancreas. Cytokeratin stained brain, glandular cells of pituitary and tubular cells of kidney. CEA did not stain these tissues. Specificity of both antibodies was shown with appropriate staining of cells of enithelial origin and no staining of cells of endodermal origin.
Sensitivity: The sensitivity of this antibody was shown by consistent staining of 9 of 10 breast and 10 of 10 colon malignancies, and appropriate staining of normal epithelial tissue.
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
K94034J
DEC 2 3 1996
510(k) Summary of Safety and Effectiveness
Ventana Medical Systems, Inc. developed the Ventana CEA Primary Antibody for use on the Ventana ES automated slide staining system. Ventana CEA Primary Antibody (clone TF 3H8-1) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2) in that they both stain antigens on cells of epithelial origin.
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Paraffin embedded preparations from normal and pathologic samples were tested using the Ventana CEA Primary Antibody and a commercially available anti-human cytokeratin. 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 on a blinded basis for specific staining intensity and background staining.
Results
Staining with both antibodies occurred in the epithelial cells of normal breast, anexal glandular cells of skin, glandular cells of stomach, prostate and pancreas.
Cytokeratin stained brain, glandular cells of pituitary and tubular cells of kidney. CEA did not stain these tissues. Since the antigens are different, it would not be expected to have 100% concordance. There was however, no inappropriate staining of tissue by either of the antibodies.
When compared with the commercially available anti-human cytokeratin antibody, Ventana CEA Primary Antibody stained the same tissues 78% of the time for enithelial line cancers. Neither Ventana CEA Primary Antibody nor the commercially available cytokeratin antibody stained any of the non-epithelial or non-mesothelial type cancers.
Specificity of both antibodies was shown with appropriate staining of cells of enithelial origin and no staining of cells of endodermal origin. In addition, the specificity seen in this study agrees with the data published by (Verstijnen et al., Anticancer Research 6:97-104. 1986).
The sensitivity of this antibody was shown by consistent staining of 9 of 10 breast and 10 of 10 colon malignancies, and appropriate staining of normal epithelial tissue. As with any immunohistochemical reagent, the sensitivity is dependent on fixation, tissue processing, and slide preparation parameters.
The negative control which was run with each tissue gave negative results with one exception. In this case, the negative control gave the same score as the non-specific
1
background (1+) which indicates that there was some inteference due to the tissue and not the specific antibody.
Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs with equivalent staining in all 16 slides. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run with equivalent staining in all ten slides.