(1135 days)
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No
The summary describes a monoclonal antibody used for immunohistochemistry, a laboratory technique. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The evaluation is performed by a qualified pathologist.
No
This device is an antibody used to aid in the diagnosis of anaplastic tumors, not to treat them.
Yes
The device is explicitly stated to "aid in diagnosis of anaplastic tumors" in the "Intended Use / Indications for Use" section.
No
The device description clearly states it contains a mouse monoclonal antibody, which is a biological reagent, not software. The performance studies involve staining tissue samples and evaluating them visually, indicating a physical product used in a laboratory setting.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "may be used to aid in the identification of abnormal cells of melanocytic lineage as an aid in diagnosis of anaplastic tumors." This indicates that the device is used to examine specimens derived from the human body (tissue samples) to provide information for diagnostic purposes.
- Device Description: The device is an antibody used to detect a specific marker (a glycoconjugate) within tissue samples. This is a common type of reagent used in in vitro diagnostic tests.
- Testing Process: The description of the test set and performance studies involves testing the antibody on formalin-fixed paraffin-embedded tissue samples, which are specimens taken from the human body. The evaluation is performed by a qualified pathologist, which is typical for IVD tests used in a clinical setting.
- Performance Studies: The performance studies evaluate the specificity and sensitivity of the antibody in detecting melanoma tumors in tissue samples. These are key metrics used to assess the performance of IVD devices.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits this definition as it is a reagent used to aid in the diagnosis of anaplastic tumors by identifying specific cells in tissue samples.
N/A
Intended Use / Indications for Use
Ventana Medical Systems' Anti-Human Melanosome(Clone HMB45) may be used to aid in the identification of abnormal cells of melanocytic lineage as an aid in diagnosis of anaplastic tumors.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Ventana Medical Systems' Anti-Human Melanosome(Clone HMB45) contains a mouse monoclonal antibody directed against a 10kD neuraminidase sensitive sialylated glycoconjugate present in immature melanosomes.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Study: Formalin fixed paraffin embedded preparations from normal and pathologic samples were tested using the Ventana Anti-Human Melanosome Antibody. 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 cytoplasm of melanoma cells. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.
Specificity of the antibody was shown by no staining of normal cells of 75 normal tissues and staining of cells of melanoma tumors.
The sensitivity of this antibody was shown by consistent staining of 19 of 20 melanoma tumors. This agrees with the report Gowan and associates where 60 of 62 melanomas showed positive staining.
Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs using the antibody and DAB detection kits. Sixteen of 16 stained positively. All slides has similar staining intensity. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run using the antibody and DAB detection kits. Ten of 10 slides stained positively. All slides stained with equivalent staining intensity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity was shown by no staining of normal cells of 75 normal tissues and staining of cells of melanoma tumors.
Sensitivity was shown by consistent staining of 19 of 20 melanoma tumors.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
K94170
APR 22 1997
anada
Anton
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' Anti-Human Melanosome(Clone HMB45) may be used to aid in the identification of abnormal cells of melanocytic lineage as an aid in diagnosis of anaplastic tumors. Anti-Human Melanosome(Clone HMB45) specifically binds to an oncofetal antigen present within immature melanosomes in the cytoplasm of melanoma cells and prenatal and infantile epithelium. This product is substantially equivalent to the same clone sold by a different manufacturer .
Ventana Medical Systems' Anti-Human Melanosome(Clone HMB45) contains a mouse monoclonal antibody directed against a 10kD neuraminidase sensitive sialylated glycoconjugate present in immature melanosomes . Melanoma metastases from axillary lymph node finely minced in phosphate buffered saline was used as the immunogen. The spleen from a BALB/c mouse injected intraperitoreally with the minced tissue was fused with NS-1 cells. Hybridomas were screened by immunocytochemistry on Carnoy's fixed, paraffin-embedded sections of the same melanoma that was used as an immunogen´.
In normal tissues. HM845 has been shown to react with immature melanosomes in fetal and neonatal melanocytes and infantile retinal pigment epithelium'-. It does not react with normal resting adult melanocytes, regardless of the degree of pigmentation 3.0 The presence of the antigen indicates active melanosome
formation and thus melanocytic differentiation? - Adult melanocytes are capable of re-expressing the fetal antigen upon activation. Melanocytes activated by a variety of stimuli have been observed. For example, HMB45 positive cells have been detected in tissue overlying or adjacent to grandation tjssue, hemangionas, vessel -rich tumor stroma, and basa1 cell
carcinomas: 3.14. - Occasional pigmented cells of hair follicles have beerved with melanocytes in lentigines or overlying fibroblastic proliferations, such as keloids, dermatofibromas and old fibrotic hemangiomas . HMB45 does not appear to react with any non-melanocytic tissues, and its expression in adults is confined to neoplastic melanocytic cells'.
Many fetal antigens are re-expressed in oncogenic tissue. In malignant cells,
HMB45 stains most primary and metastatic melanomas-3.4.5.10 . Several investigators have confirmed the high sensitivity and specificity of HMB45 for me1anoma3.4.s Desmoplastic malignant melanomas infrequently express the HMB45 antigen, possibly because they contain few melanosmes and have a mesenchymal
pattern of differentiation · Non melancytic tumor cells of epithelial, Tymphoreticular, glial and mesenchymal origin are not labeled; 13 lymphoreticular. glial and mesenchymal origin are not labeled: ". except for related antigen located in the myoid component of RAML appears to be similar to the HMB45 antigen present in melanomas 2
HMB45 is reactive with "activated" melanocytes as seen in melanomas, junctional nevi, junctional components of compound nevi, Spitz nevi, and cellular blue nevi, while it is nonreactive with common acquired and
intradermal nevi and intrademal components of compound nevif 3.3.3. Because of this differential staining on pigmented cells, HMB45 immunostaining may be a
1
useful adjunct for measuring the Breslow depth of melanomas, since it is positive on melanoma cells and negative on deep nevi cells that may accompany melanomas6.7 Unfortunately, HMB45 is not useful in distinguishing benign and malignant melanocytic proliferation because it recognizes junctional nevi. Spitz tumors and atypical melanocytic hyperplasia´.
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Formalin fixed paraffin embedded preparations from normal and pathologic samples were tested using the Ventana Anti-Human Melanosome Antibody. Samles 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 cytoplasm of melanoma cells. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.
Specificity of the antibody was shown by no staining of normal cells of 75 normal tissues and staining of cells of melanoma tumors.
The sensitivity of this antibody was shown by consistent staining of 19 of 20 melanoma tumors. This agrees with the report Gowan and associates where 60 of 62 melanomas showed positive staining. 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 based on samples of the same tissue on 16 different instrument runs using the antibody and DAB detection kits. Sixteen of 16 stained positively. All slides has similar staining intensity. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run using the antibody and DAB detection kits. Ten of 10 slides stained positively. All slides stained with equivalent staining intensity.
References
- Kapur RP, Bigler SA, Skelly M. Gown AM: Anti-melanoma monoclonal 1 . antibody HMB45 identifies an oncofeatal glycoconjugate associated with immature melanocytes. J Histochem Cytochem 1992;40:20/-212.
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- Gown AM, Vogel AM, Hoak D, Gough F, McNutt MA: Monoclonal antibodies specific for melanocytic tumors distinguish subpopulations of melanocytes. Am J Patho7 1986;123:195-203.
- Colombari R. Bonetti F. Zamboni G. Scarpa A. Marino F. Tomezoli A.
Capelli P. Mestraina F. Chilosi M. Fiore-Donati L. Distribution of 3.
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melanoma specific antibody (HMB45) in benign and malignant melanocytic tumors. Virchows Archiv A Pathol Anat 1988;413:17-24.
- Ordonez NG, Xiaolong J. Hickey RC: Comparison of HMB45 monoclonal 4. antibody and S-100 protein in the immunohistochemical diagnosis of melanoma. Am J Clin Pathol 1988;90:385-390.
- Wick MR, Swanson PE, Rocamora A: Recognition of malignant melanoma by ട്. monoclonal antibody HMB45. An immunohistochemical study of 200 paraffinembedded cutaneous tumors. J Cutan Pathol 1988;15:201-207.
- Taylor RT and Cote RJ. Immunomicroscopy: A Diagnostic Tool for the 6. Surgical Pathologist. W.B. Saunders Company. Philadelphia, 1994.
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- Duray PH, Palazzo J. Gown AM, Ohuchi N. Melanoma cell heterogeneity. A study of two monoclonal antibodies compared with S-100 in paraffin sections. Cancer 1988: 61:2460-2468.
- Esclamado RM, Gown AM, Vogel AM. Unique proteins defined by monoclonal 8. antibodies specific for human melanoma. Am J Surg 1986:152:376-385.
- Smoller BR, McNutt NS, Hsu A. HMB45 recognizes stimulated melanocytes. g . J. Cutan Pathol 1989; 16:49-53.
- Smoller BR, Hsu A. Krueger J. HMB45 monoclonal antibody recognizes an 10. inducible and reversible melanocyte cytoplasmic protein. J Cutan Pathol 1991: 18:315-322.
- Pea M. Bonetti F, Zamboni G, Martignoni G, Riva M, Colombari R, Mombello 11. A, Bonzanini M, Scarpa A, Ghimenton C, Donati LF. Melanocyte-marker-HMB45 is regularly expressed in angiomyolipoma of the kidney. Pathol 1991; 23:185-188.
- Ashfaq R, Weinberg AG, Albores-Saavedra J. Renal angiomyolipomas and 12. HMB45 reactivity. Cancer 1993; 71:3091-3097.
- Skelton HG. Smith KJ. Barrett TL. Lupton GP, Graham JH. HMB45 staining 13. in benign and malignant melanocytic lesions. Am J Derm 1991; 13:543-550.