(875 days)
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No
The device description and performance studies focus on an antibody used in an automated immunohistochemistry system, with no mention of AI or ML.
No
This device is an antibody used for laboratory testing on tissue samples, not for treating patients.
Yes
The device is an antibody used in immunohistochemistry to stain tissue samples, which aids in the visual diagnosis of various cancers by identifying specific cell types (epithelial origin). The performance studies compare its staining efficacy for diagnostic purposes.
No
The device description clearly states it is a "Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system," indicating it is a physical reagent (antibody) used with a hardware system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It's a "Primary Antibody" used on an "automated immunohistochemistry system." Antibodies used in immunohistochemistry are reagents that bind to specific targets in tissue samples to aid in diagnosis.
- Anatomical Site: It lists a wide range of human tissues (colon, breast, prostate, etc.) where it is used. This indicates it's used to analyze human biological samples.
- Description of the test set: It describes testing on "Paraffin embedded preparations from normal and pathologic samples" and evaluating "specific staining intensity and background staining." This is a typical process for in vitro diagnostic tests performed on tissue samples.
- Summary of Performance Studies: It details a "Comparative Study" comparing the antibody's performance to a "commercially available anti-human cytokeratin antibody" in staining "epithelial line cancers" and "normal tissues." This type of study is conducted to demonstrate the performance of an IVD.
- Key Metrics: It mentions "Specificity" and "Sensitivity," which are key performance metrics for IVD tests.
- Predicate Device(s): It lists a "commercially available anti-human cytokeratin (clone CAM 5.2)" as a predicate device. Predicate devices are typically other legally marketed IVDs that the new device is being compared to.
All of these points strongly indicate that this device is intended for use in the in vitro 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
Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.
Product codes
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Device Description
Ventana Keratin Primary Antibody (clone 5D3) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2).
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
Paraffin embedded preparations from normal and pathologic samples were tested using Ventana Keratin Primary Antibody and a commercially available anti-human cytokeratin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included colon carcinomas, breast carcinomas, prostatic carcinomas, adenocarcinoma, squamous cell carcinomas and nonepithelial cancers. Normal tissues examined were breast, ureter, thyroid, skin, small intestine, stomach, liver, adrenal, muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, kidney, connective tissue and salivary gland. Slides were processed on the Ventana 320 Automated Slide Stainer and prepared for examination, then evaluated on a blind 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 Ventana Keratin Primary Antibody and a commercially available anti-human cytokeratin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included colon carcinomas, breast carcinomas, prostatic carcinomas, adenocarcinoma, squamous cell carcinomas and nonepithelial cancers. Normal tissues examined were breast, ureter, thyroid, skin, small intestine, stomach, liver, adrenal, muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, kidney, connective tissue and salivary gland. Slides were processed on the Ventana 320 Automated Slide Stainer and prepared for examination, then evaluated on a blind basis for specific staining intensity and background staining.
Results: When compared with a commercially available anti-human cytokeratin antibody. Ventana Keratin Primary Antibody stained the same tissues 91% of the time in epithelial line cancers. Neither Ventana Keratin Primary Antibody nor the commercially available antibody stained any of the nonepithelial type cancers. The staining patterns of the normal tissues were considered to be appropriate. Staining intensity was scored on a scale of 0 - 4+. Non parametric analysis of the staining intensity results (Wilcoxon matched pairs) shows no difference in the performance of the two antibodies tested, even at the .01 level of significance. Specificity of both antibodies was proven with appropriate staining of cells of epithelial origin and no staining of cells of mesodermal or endodermal origin. Sensitivity of keratin antibodies, based on comparison of 37 epithelial line cancers. showed that Ventana Keratin Primary Antibody stained 30 of 37 and the commercially available anti-human cytokeratin antibody stained 31 of 37. Inter-run reproducibility, based on samples of the same tissue on 16 different instrument runs, and intra-run reproducibility, based on 10 samples of the same tissue within one run, were identical for both antibodies. The mean staining intensity and standard deviation of each antibody was 2.5 ± 0.00.
Key Metrics
Sensitivity: Ventana Keratin Primary Antibody stained 30 of 37 epithelial line cancers; commercially available anti-human cytokeratin antibody stained 31 of 37 epithelial line cancers.
Specificity: proven with appropriate staining of cells of epithelial origin and no staining of cells of mesodermal or endodermal origin.
Staining intensity: scored on a scale of 0 - 4+. Mean staining intensity and standard deviation of each antibody was 2.5 ± 0.00.
Agreement: 91% of the time in epithelial line cancers.
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
MAR 22 1999
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510(k) Summary of Safety and Effectiveness
Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system. Ventana Keratin Primary Antibody (clone 5D3) is substantially equivalent to a commercially available anti-human cytokeratin (clone CAM 5.2).
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 Ventana Keratin Primary Antibody and a commercially available anti-human cytokeratin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included colon carcinomas, breast carcinomas, prostatic carcinomas, adenocarcinoma, squamous cell carcinomas and nonepithelial cancers. Normal tissues examined were breast, ureter, thyroid, skin, small intestine, stomach, liver, adrenal, muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, kidney, connective tissue and salivary gland. Slides were processed on the Ventana 320 Automated Slide Stainer and prepared for examination, then evaluated on a blind basis for specific staining intensity and background staining.
Results
When compared with a commercially available anti-human cytokeratin antibody. Ventana Keratin Primary Antibody stained the same tissues 91% of the time in epithelial line cancers. Neither Ventana Keratin Primary Antibody nor the commercially available antibody stained any of the nonepithelial type cancers. The staining patterns of the normal tissues were considered to be appropriate.
Staining intensity was scored on a scale of 0 - 4+. Non parametric analysis of the staining intensity results (Wilcoxon matched pairs) shows no difference in the performance of the two antibodies tested, even at the .01 level of significance.
Specificity of both antibodies was proven with appropriate staining of cells of epithelial origin and no staining of cells of mesodermal or endodermal origin. Sensitivity of keratin antibodies, based on comparison of 37 epithelial line cancers. showed that Ventana Keratin Primary Antibody stained 30 of 37 and the commercially available anti-human cytokeratin antibody stained 31 of 37.
Inter-run reproducibility, based on samples of the same tissue on 16 different instrument runs, and intra-run reproducibility, based on 10 samples of the same tissue within one run, were identical for both antibodies. The mean staining intensity and standard deviation of each antibody was 2.5 ± 0.00.