(85 days)
Not Found
Not Found
No
The device description focuses on a monoclonal antibody for immunohistochemistry, and there is no mention of AI, ML, or image processing for analysis. The intended use is to aid in identification by light microscopy, which is a manual process interpreted by a pathologist.
No.
This device is an in vitro diagnostic (IVD) tool used to aid in the identification of T-cell lineage cells by staining specific antigens in tissue samples for microscopic examination, rather than providing direct therapy or treatment.
Yes
This device qualitatively aids in the identification of human cells of T-cell lineage to assist in the classification of lymphomas. This diagnostic purpose is clearly stated in the "Intended Use / Indications for Use" section.
No
The device description clearly states it is comprised of a mouse monoclonal antibody, which is a biological reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used "to qualitatively aid in the identification by light microscopy of human cells of T-cell lineage... in normal and pathologic paraffin embedded tissues". This involves testing a sample taken from the human body (tissue) outside of the body (in vitro) to provide information for diagnostic purposes (aiding in the classification of lymphomas).
- Device Description: The device is a reagent (antibody) used to detect a specific antigen (CD45RO) in tissue samples. This is a typical component of an in vitro diagnostic test.
- Input Imaging Modality: Light microscopy is a common method for examining stained tissue samples in diagnostic pathology.
- Anatomical Site: The target is human tissue, specifically lymphocytes of T-cell lineage.
- Intended User / Care Setting: "Laboratory use" is consistent with the use of an IVD in a clinical laboratory setting.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or for the assessment of health.
N/A
Intended Use / Indications for Use
FOR IN VITRO DIAGNOSTIC USE. ChemMate™ UCHL1 (CD45RO) is intended for laboratory use to qualitatively identify by light microscopy human lymphocytes of T-cell lineage in normal and pathological paraffin embedded tissues processed in zinc formalin, neutral buffered formalin, Bouin's or B5 fixative. Positive results aid in the classification of lymphomas as T-cell in origin and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphological criteria and multiple chemical and immunohistochemical stains.
To qualitatively aid in the identification by light microscopy of human cells of T-cell lineage, by recognizing CD45RO antigen in normal and pathologic paraffin embedded tissues processed in neutral buffered formalin, 85, or Bouin'a fixative. Positive results aid in the classification of lymphomas as T-cell in origin and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphological criteria and multiple chemical and immunochemical stains.
Product codes
DEM
Device Description
ChemMate™ UCHL1 (CD45RO) is comprised of a mouse monoclonal antibody, clone UCHL1, and is of the IgG2a, Kappa light chain class of immunoglobulins¹. The antibody reacts with the 180kD low molecular weight isoform of CD45 or leukocyte common antigen (LCA/CD45) family. The 180kD glycoprotein occurs on most thymocytes and activated T cells, and on a proportion of resting T cells. Additionally the antibody is reactive with a subpopulation of resting T cells within both the CD4 and CD8 subsets. Granulocytes and monocytes are also reactive with UCHL1 while most normal B cells and NK cells are unreactive. UCHL 1 has been classified as a CD45RO antibody by the Fourth International Workshop on Human Leukocyte Differentiation Antigens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light microscopy
Anatomical Site
human lymphocytes of T-cell lineage in normal and pathological paraffin embedded tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory use / interpreted by a pathologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Reproducibility: ChemMate™ UCHL1 (CD45RO) has been tested on serial sections of tissue specimens. Consistent staining results have been obtained with run to run and within run antibody testing.
Immunoreactivity: The following immunoreactivities have been demonstrated in paraffin-embedded tissues. The list provided below is not exhaustive but characterizes the types of immunoreactivity reported in the literature for the UCHL1 clone contained in the monoclonal antibody cocktail of the ChemMate™ UCHL1 (CD45RO).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).
0
KY115084
510(k) Summary
OCT - 3 1997
Date: September 29, 1997
VENTANA MEDICAL SYSTEMS, INC. 3865 North Business Center Drive Tucson, Arizona 85705
(520) 887-2155 Telephone: (520) 887-2558 Facsimile:
Stephen A. Tillson, Ph.D. Contact: Vice President Scientific Affairs/ Quality Assurance
2028492 Registration #:
ChemMate™ UCHL1 Trade Name:
Class II
FOR IN VITRO DIAGNOSTIC USE. Intended Use:
ChemMate™ UCHL1 (CD45RO) is intended for laboratory use to qualitatively identify by light microscopy human lymphocytes of T-cell lineage in normal and pathological paraffin embedded tissues processed in zinc formalin, neutral buffered formalin, Bouin's or B5 fixative. Positive results aid in the classification of lymphomas as T-cell in origin and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphological criteria and multiple chemical and immunohistochemical stains.
This mouse monoclonal antibody has been optimally prediluted for use with the ChemMate™ SDK605 Secondary Detection - Peroxidase/DAB kit. Additionally, the prediluted ChemMate™ UCHL1 (CD45RO) antibody as well as the ChemMate™ SDK605 Secondary Detection - Peroxidase/DAB kit has been optimized for use with the Techmate™ for automated immunohistochemical staining.
1
510K SUMMARY OF SAFETY AND EFFECTIVENESS
Summary And Explanation
ChemMate™ UCHL1 (CD45RO) is comprised of a mouse monoclonal antibody, clone UCHL1, and is of the IgG2a, Kappa light chain class of immunoglobulins¹. The antibody reacts with the 180kD low molecular weight isoform of CD45 or leukocyte common antigen (LCA/CD45) family.23 The 180kD glycoprotein occurs on most thymocytes and activated T cells, and on a proportion of resting T cells. Additionally the antibody is reactive with a subpopulation of resting T cells within both the CD4 and CD8 subsets.4 Granulocytes and monocytes are also reactive with UCHL1 while most normal B cells and NK cells are unreactive. 15 UCHL 1 has been classified as a CD45RO antibody by the Fourth International Workshop on Human Leukocyte Differentiation Antigens.5
In a broad study. Smith et al. utilized fluorescent activated cell sorting techniques with UCHL1 to outline the reactivity of this antibody. UCHL1 was shown to stain granulocytes, monocytes, most thymocytes, 72% of CD4+ cells 36% of CD8+ cells, a number of T-cell lines and some neoplastic B-cell lines. Normal B-cell and NK cells were unreactive. On frozen sections of tonsil and spleen. UCHL1 labeled cells in known T-cell areas. The authors concluded that UCHL1 detects a subset of T-cells and may be useful in studying immune disorders by detecting changes in T-cell subsets.1 Poppema et al. also reviewed the immunoreactivity of UCHL1 on normal Ivmphoid tissues and lymphomas as well as lymphocyte cytospin preps and LCA transfected cell lines. Their results with UCHL1 demonstrated reactivity with 60% of cells in T-cell areas of spleen, tonsil and lymph nodes and primarily with cortical thymocytes of the thymus. Additionally UCHL1 strongly stained peripheral blood monocytes and granulocytes. It was further noted that UCHL1 recognized a 180 kD band on a Western blot and was positive in 10 of the 12 T-cell lymphomas. In a study involving a panel of antibodies on paraffin-embedded fixed tissue, UCHL1 was emploved by Linder et al. They also reported that UCHL1 positively labeled T-lymphocytes in human tonsil and specifically, greatly labeled greater than 75% of interfollicular cells, less than 10% of the follicular mantle cells, and weakly labeled less than 10% of the cells in the germinal centers.8
Wieczorek, et al. employed UCLH1 in an immunohistochemical study on routinely fixed paraffin-embedded tissues known to contain neoplastic T cells. UCHL1 was reactive in both formalin and Bouin's fixed paraffin-embedded tissues. Further, the antibody was positive in 17 out of 28 T-cell non Hodgkin's lymphomas tested , only 1 of 17 Hodgkin's disease cases and only 2 of the 35 B-cell non-Hodgkin's lymphoma cases examined. 9
2
Using 50 formalin-fixed paraffin-embedded archival cases of T-cell Ivmphomas, previously diagnosed by immunochemistry and/or gene rearrangement. Cabecadas and Isaacson further characterized those T-cell lymphomas by low or high grade and histological type. While the lymphomas were heterogenous for a number of antibodies used in the panel, results with UCHL1 revealed positive membrane staining in 47 out of 50 cases.10 Further, Shin et al. were able to determine the immunophenotypes of Reed-Sternberg (RS)-like cells upon re-analysis of 19 low-grade lymphomas using immunohistochemistry. Previously linked to high-grade lymphoma and resembling true Reed-Sternberg cells of Hodgkin's disease, the Reed-Sternberg-like cells were successfully identified with immunohistochemical results as re-transformed neoplastic cells of B-cell lineage. Accordingly, UCHL1 was unreactive in all of these low grade lymphomas.11 And in a study involving 49 formalin-fixed and paraffin-embedded cutaneous malignant lymphomas and disorders, diagnosed by histologic criteria, Hauschild and Sterry determined 29 of these cases to be T-cell lymphomas. UCHL-1 was reactive with 27 of the 29 T-cell Ivmphomas as follows: 12 of 12 mycosis fungoides lymphomas, 12 of 12 pleomorphic T-cell lymphomas, 2 of 2 Sezary's Syndrome and with 1 of 3 large anaplastic T-cell lymphomas.12 Clark et al. employed UCHL1 on B-5 fixed paraffin- embedded reactive or neoplastic lymphoid and hematopoietic proliferative disorders, diagnosed by histologic criteria. They reported that UCHL1 labeled 29 of 37 T-cell lymphomas and only 1 of 54 B-cell neoplasms. Additionally, UCHL1 was negative in all Hodgkin's disease with 24 of 32 cases exhibiting Reed-Sternberg cell-nonreactivity and 8 of 32 cases exhibiting variable Reed-Sternberg-cell positivity. Only 1 of 15 leukemias stained positively with UCHL1. In the reactive lymph nodes, UCHL1 labeled cells in the interfollicular areas and sparsely labeled cells in follicular centers and the mantle zone. Dermatopathic T-zone nodules showed less that 25% of cells as UCHL1 positive.13
Using a small panel of antibodies, including UCHL1, Segal et al. also conducted a study encompassing B-5 fixed, paraffin-embedded neoplastic and lymphoid proliferative diseases. All cases had been previously immunotyped through immunohistochemistry and genotypic analyses. UCHL1 was reactive in 0 of the 74 B-cell malignant lymphomas and was reactive in 3 of the 5 malignant T-cell lymphomas. 14 Additionally, Andrade et al. used a panel of antibodies, including UCHL1 to immunophenotype hematopoietic malignancies. These cases had been originally phenotyped in cell suspensions or frozen sections by direct and indirect immunofluorescence. UCHL1 was unreactive in 27 neoplasms of B-cell origin, 4 cases of extramedullary leukemia, 5 cases of Hodgkin's disease and 5 cases of histiocytic neoplasms and reactive in 9 of 11 T-cell lymphomas.15 Macon et al. reported that UCHL1 was reactive in 53 of 77 peripheral T-cell
3
Ivmphomas and reactive in only 3 of 39 B-cell Ivmphomas and 3 of 11 Hodgkin's lymphomas.16 Further, in a study which encompassed 28 cases of Hodgkin's disease and anaplastic large cell lymphomas (ALCL), Leoncini et al, employed histologic diagnosis to demonstrate that UCHL1 was positive in 1 of 13 Hodakin's disease whereas it positively labeled 5 of 11 cases of ALCL. UCHL1 was positive in 1 of the remaining 4 cases of undetermined status.17 Myskow et al. applied a panel of monoclonal antibodies, including UCHL1 to a series of formalin-fixed paraffin-embedded B and T cell non-Hodokin's Ivmphomas of various subtypes that had been characterized previously by frozen-section immunophenotyping. UCHL 1 was reactive in 2 of 14 low grade B-cell lymphomas and 8 of 30 high-grade B-cell lymphomas, including 7 of 14 centroblastic (large non-cleaved cell) lymphomas. Additionally, UCHL1 positively labeled 23 of 32 T-cell Ivmphomas 18 And, Ngan et al. used a panel of antibodies, including UCHL1. on paraffin sections of non-Hodgkin's lymphoma that had been previously diagnosed based on immunohistochemical staining of cryostat sections. Results revealed that UCHL1 was unreactive in all 77 of the B-cell lineage lymphomas. 19
Consistent with its cross-reactivity with myeloid lineage cells. UCHL-1 positive membrane staining has been noted with mature myeloid cells in granulocytic sarcomas, and macrophages in histiocytic Ivmphomas, malignant histiocytosis of the intestine and Langerhans Cell histiocytosis20.24 Morphological studies and the use of UCHL-1 in a panel of antibodies are recommended for use in the differential diagnosis of granulocytic sarcoma, plasmacytoma, and histiocytic neoplasia from T-cell lymphomas.
In summary, UCHL1, is a useful aid in the diagnosis of neoplasms of T cell lineage. However, it does not stain all T cell Ivmphomas and does stain some lymphomas of B cell origin. This antibody is a useful tool in the differential diagnosis of lymphomas when used as a part of a panel of appropriate antibodies.
Product Specific Limitations:
-
- In poorly fixed tissue specimens, nonspecific staining of non-lymphoid tissues may be observed, particularly epithelium and smooth muscle.
-
- Occasional cases of T-cell lymphoma have been reported to co-express the CD45RO antigen.
-
- It is important to differentiate between the ring-like membrane staining pattern associated with a T-cell lineage and the nonspecific cytoplasmic and nuclear staining. Nuclear staining may represent cross-reactivity with an unknown nuclear antigen.26 Nonspecific cvtoplasmic staining has been reported in smooth muscle, hepatocytes, squamous and transitional
4
epithelium, gall bladder and breast tissue.20 No other UCHL1 reactivity has been noted with normal or malignant non-lymphoid cells.8
-
- Staining has been detected in select groups of B-cell pathological tissues. A few cases of diffuse large cell (9/50, 18%) non-Hodgkin's B-Cell Ivmphomas coexpress the CD45RO antigen 6 8 13. One group8 has reported weak membrane staining in scattered Reed-Sternberg cells in some cases of Hodgkin's Disease (8/32, 25%), while other groups report no staining of Reed-Sternberg cells.8.20 Petruch et al., 21 reported UCHL1 positive neoplastic plasma cells in 24/51 (47%) of plasmcvtomas/multiple myelomas tested. Weak, nonspecific cytoplasmic staining may also be seen in some large cell lymphomas of B-cell origin and myelomas $, 00
-
- In Hodgkin's disease, Reed-Sternberg cells are predominantly negative for UCHL1. However, there have been some reports of variable positive staining with UCHL1 in Reed-Sternberg cells. 8,9,13,14
-
- UCHL1-positive B-cells may be present in tissues other than those of lymphoid origin. Though these reactions are positive for UCHL1, interpretation should always be considered within the context of the predominant cell type of the tissue in question.
-
- Occasional staining of intraluminal secretions, surface epithelium and cytoplasm has been reported in breast fibroadenoma and fibrocystic disease with DAKO® CD4525 and DAKO® CD45RO, UCHL-1 antibodies.
-
- Because UCHL1 does not stain all T-cells, the absence of staining does not exclude the absence of T-cell lineage. This antibody is a useful tool as long as it is used as a part of a panel of antibodies.
Performance Characteristics:
Reproducibility: ChemMate™ UCHL1 (CD45RO) has been tested on serial sections of tissue specimens. Consistent staining results have been obtained with run to run and within run antibody testing.
Immunoreactivity: The following immunoreactivities have been demonstrated in paraffin-embedded tissues.. The list provided below is not exhaustive but characterizes the types of immunoreactivity reported in the literature for the UCHL1 clone contained in the monoclonal antibody cocktail of the ChemMate™ UCHL1 (CD45RO).
5
TABLE I REACTIVE NORMAL TISSUES/CELLS 14.5.7.8.10
| Tissues | Cells |
|---|---|
| *Lymph Node: | |
| germinal center T-cells | |
| mantle zone lymphocytes (most cells) | Thymocytes: |
| activated T cells | |
| resting T cells | |
| *Spleen: | |
| white pulp areas | |
| periarteriolar lymphatic sheath | |
| red pulp areas | |
| granulocytes | |
| monocytes | Granulocytes |
| *Tonsil: | |
| germinal center T-cells | |
| (scattered positive) | |
| interfollicular T-cells | |
| follicular mantle T lymphocytes | |
| (scattered positive) | |
| *Thymus: | |
| cortical thymocytes | |
| medullary thymocytes (scattered) | |
| Whole Blood (Peripheral): | |
| circulating T lymphocytes | |
| monocytes | Monocytes |
| Cytospins of peripheral blood: | |
| monocytes | |
| granulocytes | |
| macrophages |
- In paraffin embedded tissue7, 8, 10
6
NONREACTIVE NORMAL TISSUES/CELLS1,7,8,12 TABLE II
Non-Lymphoid Tissues Thyroid Lung Breast Pancreas Liver Prostate Kidney Uterus Muscle
7
TABLE III NEGATIVE NON-LYMPHOID PATHOLOGICAL TISSUES/CELLS®, 22, 23
| Epithelial | Endocrine |
|---|---|
| Adenocarcinoma: | |
| Breast | |
| Colon | |
| Lung | |
| Ovary | |
| Prostate | |
| Thyroid | Neuroendocrine: |
| Thyroid, medullary carcinoma | |
| Ameloblastoma | Mixed |
| Carcinoma: | |
| Squamous cell | |
| Uterine | |
| Cervix | |
| Lung | |
| Skin | |
| Small cell | |
| Non-keratinizing | |
| Undifferentiated | Neuro: |
| Anaplastic astrocytoma | |
| Neurofibroma | |
| Neuroblastoma | |
| Mesothelioma | Small Cell Tumors: |
| Ewings Sarcoma | |
| Melanoma | |
| Mesenchymal | |
| Chondrosarcoma, extraskeletal | |
| myxoid | |
| Malignant Fibrous Histiocytoma | |
| Rhabdomyosarcoma | |
| Alveolar |
Case numbers not reported for the majority of the cases listed above.
8
TABLE IV: NON-HODGKIN'S LYMPHOMAS and OTHER LYMPHOPROLIFERATIVE DISORDERS
| TISSUE | T-CELL | % | 95% CI | B-CELL | % | 95% CI |
|---|---|---|---|---|---|---|
| Non-Hodgkin's Lymphomas: | 266/394 | 68% | 63-72.5% | 42/461 | 9% | 7.0-12.5% |
| T-Cell Lymphoma:7,8,12,13,15,16,18,19 | 73/92 | 79% | 68.5-87% | 0/4 | -- | 0-60.2% |
| -Unspecified | 40/51 | 78% | 64-88.5% | 0/4 | -- | 0-60.2% |
| -Cutaneous | 19/24 | 79% | 57.5-92.5% | |||
| -Mycosis Fungoides | 14/17 | 82% | 56-96% | |||
| Low Grade: 8,9,10,11,12,13,15,16,18,19,22 | 87/117 | 74% | 65-82% | 7/256 | 3% | 2.0-6.5% |
| -Small Lymphocytic | 19/23 | 83% | 62-95% | 1/40 | 3% | 0.1-14% |
| -Follicular center cell | 3/77 | 4% | 1.0-12% | |||
| -Small cleaved, follicular & diffuse | 8/9 | 89% | 50-99.5% | 0/60 | 0-6.5% | |
| -Mixed, diffuse | 48/61 | 79% | 67-88% | 1/12 | 8% | 0.8-38% |
| -Large cleaved | 0/3 | -- | 0-70.8% | |||
| -Large diffuse | 12/24 | 50% | 22-78% | 2/55 | 4% | 0.9-13.5% |
| -Large follicular | 0/9 | -- | 0-34% | |||
| Intermediate: | 11/13 | 85% | 57-97% | 2/64 | 3% | 0.5-10.5% |
| -Large cell | 3/5 | 60% | 19-92% | 1/38 | 3% | 0.2-18% |
| -Cleaved, diffuse | 4/4 | 100% | 39.8-100% | 0/6 | -- | 0-45.9% |
| -Mixed, diffuse | 3/3 | 100% | 29.2-100% | 0/2 | -- | 0-84.7% |
| -Large, diffuse | 1/1 | 100% | 1/18 | 6% | 0.1-28% | |
| High Grade: 8,9,10,12,14,15,16,17,18 | 56/102 | 55% | 48-64% | 8/122 | 7% | 3.5-13% |
| -Small non-cleaved | 1/8 | 12.5% | 0.5-53% | |||
| -Large immunoblastic | 25/40 | 63% | 47-78% | 0/23 | -- | 0-14% |
| -Immunoblastic clear cell | 6/17 | 35% | 13.5-62% | |||
| -Large lymphoblastic | 10/19 | 53% | 29.5-75.5% | 0/3 | -- | 0-70.8% |
| -Malignant | 6/8 | 75% | 33.5-96.5% | 7/88 | 8% | 4-16.5% |
| -Anaplastic, large | 9/18 | 50% | 27-74% | |||
| Miscellaneous: 12,13,14,15,16,18,21 | 35/49 | 71% | 53-82.5% | 1/10 | 10% | 0.5-54% |
| -Sezary's Syndrome | 2/2 | 100% | 15.8-100% | |||
| -Immunoblastic Sarcoma | 20/25 | 80% | 56-94% | 0/5 | -- | 0-52% |
| -Marginal Zone Lymphoma | 0/1 | |||||
| -Sinonasal Large-Cell Lymphoma | 7/16 | 44% | 20-70.5% | 1/1 | -- | |
| -Monocytoid Lymphoma | 0/3 | -- | 0-70.8% | |||
| -Lennert's Syndrome | 6/6 | 100% | 54.1-100% | |||
| Other Lymphoproliferative Disorders: | 4/21 | 19% | 5.5-42% | 24/59 | 41% | 28-54% |
| -Acute Myelogenous Leukemia | 0/1 | -- | 0/1 | -- | -- | |
| -Chronic Myelogenous Leukemia | 0/3 | -- | 0-70.8% | 0/1 | -- | -- |
| -Hairy Cell Leukemia | 0/2 | -- | 0-84.7% | |||
| -Plasmacytoma/Plasma Cell | ||||||
| Myeloma | 24/57 | 42% | 29-56% | |||
| -Malignant Histiocytes of Intestine | 4/15 | 27% | 13-55% |
Note: The number of reactive tissues over the total number of tissues is recorded by the specimen type. Confidence Intervals have been assigned for sample values greater than 1.
9
| TISSUE | NO. REACTIVE /
NO. TESTED | % | 95% CONFIDENCE
INTERVAL |
|---------------------------|------------------------------|------|----------------------------|
| Lymphocyte
Depleted | 0/4 | --- | 0-60.2% |
| Lymphocyte
Predominant | 2/6 | 33% | 1.7-98% |
| Mixed
Cellularity | 4/19 | 21% | 7-45.4% |
| Nodular
Sclerosing | 4/54 | 7.4% | 2.5-18% |
| Unclassified | 2/6 | 33% | 1.7-98% |
| Total: | 12/89 | 13% | 7.5-22.5% |
TABLE V HODGKIN'S LYMPHOMA 9,12,13,14,15,16,17
The majority of cases presented with UCHL1-negative Reed-Sternberg cells. Although Reed-Sternberg cells predominantly are unreactive for UCHL 1, occasional, scattered positive reactions were mentioned.
Note: The number of reactive tissues over the total number of tissues is recorded by the specimen type. Confidence Intervals have been assigned for sample values greater than 1.
References:
-
- Smith SH. et al. Functional subsets of human helper-inducer cells defined by a new monoclonal antibody, UCHLI. Immun. 1986, 58:63
-
- Cebrian M. et al. Three different antigen specificities within the leukocyte common antigen or T200 complex, a biochemical cell distribution, and functional comparative study. In McMichael AJ et al., eds Leukocyte Typing III. Oxford, Oxford University Press, 1987. pg 823.
-
- Terry LA, et al. The monoclonal antibody UCHL1 recognizes a 180,000 MW component of the human leukocyte common antigen, CD45. Immun. 1987, 64:331
-
- Terry L, et al. Phenotypic heterogeneity of the CD4+ and CD8+subsets. In McMichael AJ et al., eds Leukocyte Typing III. Oxford, Oxford University Press, 1987. pg 225
-
- Schwizner R. et al. Cluster report: CD45/CD45R. In Knapp W et al, eds. Leukocyte Typing IV. White Cell Differentiation Antigens. Oxford, Oxford University Press, 1989, pg 628
-
- Hall PA, et al. New marker of B lymphocytes, MB2: comparison with other lymphocyte subset markers active in conventionally processed tissue sections. J Clin Pathol. 1987, 40:151
10
-
- Poppema, S et al. Monoclonal antibody OPD4 is reactive with CD45RO, but differs from UCHL1 by the absence of monocyte reactivity. Am J Patho. 1991, 139(4): 725
-
- Linder J. et al. Monoclonal antibodies marking T lymphocytes in paraffinembedded tissue. Am J Path. 1987, 127:1
-
- Wieczorek R, et al. Monoclonal antibody Leu-22 (L60) permits the demonstration of some neoplastic T cells in routinely fixed and paraffinembedded tissue sections. Hum Path. 1988, 19:1434
-
- Cabecadas J and Isaacson P. Phenotyping of T-cell lymphomas in paraffin sections-which antibodies? Histopath. 1991, 19:419
-
- Shin S. et al. Reed-Sternberg-like cells in low-grade lymphomas are transformed neoplastic cells of B-cell lineage. Am J Clin Path. 1993. 99:658
-
- Hauschild A and Sterry W. Formalin-resistant leukocyte surface antigens in the diagnosis of cutaneous malignant lymphoma. Am J Path. 1989, 135(1):177
-
- Clark J. et al. Detection of B- and T-cells in paraffin-embedded tissue sections. Am J Clin Path. 1990. 93:58
-
- Segal GH. et al. Reliable and cost-effective paraffin section immunohistology of lymphoproliferative disorders. Am J Surg Path. 1991, 15(11):1034
-
- Andrade R, et al. Immunophenotyping of hematopoietic malignancies in paraffin sections. Hum Path. 1988, 19:394
-
- Macon WR. et al. Leu-22(L60), a more sensitive marker than UCHL 1 for peripheral T-cell lymphomas particularly large-cell types. Am J Clin Path. 1991. 95:696
-
- Leoncini L, et al. Hodgkin's disease and CD30-positive anaplastic large cell Ivmphomas: a continuous spectrum of malignant disorders. Am J Path. 1990, 137:1047
-
- Myskow M. et al. Paraffin section immunophenotyping of non-Hodgkin's lymphoma, using a panel of monoclonal antibodies. Am J Clin Path. 1988. 90:564
-
- Ngan B, et al. Immunophenotypic diagnosis of non-Hodgkin's lymphoma in paraffin sections. Am J Clin Path. 1989, 91:579
-
- Norton AJ, et al. Monoclonal antibody (UCHL-1) that recognizes normal and neoplastic T cells in routinely fixed tissue. J Clin Path 1986; 39: 399
-
- Petruch U, et al. Frequent Expression of Haemopoietic and nonhaemopoietic antigens by neoplastic plasma cells: an immunohiostochemical study using formalin-fixed, paraffin-embedded tissue. Histopath. 1992, 20:35
-
- Sugimoto T, et al. Nasopharyngeal carcinomas and malignant lymphomas: an immunohistochemical analysis of 74 cases. Laryngoscope. 1990: 100(7):782
-
- Wolf B, et al. Immunohistochemical analysis of small cell tumors of the thyroid gland. Hum Path. 1992, 23:1252
11
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- Yang WI. Immunohistochemical study on antigenic phenotype of Langerhan's cell histiocytosis. Yonsei Med J 1992; 33(4): 309
-
- Herman GE and Elfont EA. Aberrant CD45 (leukocyte common antigen) staining of non-malignant breast lesions in zinc formalin fixed tissues. J Histotech 1993, 16(2): 151
-
- Shin SS et al. Immunoarchitecture of normal human bone marrow: a study of frozen and fixed tissue sections. Hum Pathol 1992, 23:686
12
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human figures connected by flowing lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Stephen A. Tillson, Ph.D. Vice President Scientific Affair/ Quality Assurance VENTANA MEDICAL SYSTEMS, INC. 3865 North Business Center Drive Tucson, Arizona 85705
OCT - 3 1997
Re : K973389 Trade Name: ChemMate™ UCHL1 Requlatory Class: II Product Code: DEM Dated: July 7, 1997 Received: July 10, 1997
Dear Dr. Tillson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and ... . Radiological Health
Enclosure
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510(k) Number (if known):_K973389
ChemMate UCHL1 (CD45RO) Device Name:
Antibody Reagent
Indications For Use:
To qualitatively aid in the identification by light microscopy of human cells of T-cell lineage, by recognizing CD45RO antigen in normal and pathologic paraffin embedded tissues processed in neutral buffered formalin, 85, or Bouin'a fixative. Positive results aid in the classification of lymphomas as T-cell in origin and must be interpreted by a pathologist within the context of clinical data, gross and microscopic morphological criteria and multiple chemical and immunochemical stains.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tita E. Mason
(Division Sign-Off) Division of Clinical Laboratory De 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter. Use_
(Optional Format 1-2-96)
0