(203 days)
Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34βE12 (34βE12) is intended for laboratory use to qualitatively identify by light microscopy the 66, 57, 51 and 49kD3 proteins corresponding to cytokeratins 1, 5, 10 and 14 of the Moll catalog in acetone or methanol fixed, frozen and formalin, methacarn or Carnoy's fixed, paraffin embedded tissues. 34BE12 specifically binds to antigens located in the cytoplasm of normal squamous and ductal epithelial cells. Positive results aid in the classification of normal and abnormal cells and tissues and serve as an adjunct to conventional histopathology. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual.
Anti-Human Cytokeratin. High Molecular Weight, Clone 34BE12 Antibody may be used as one member of a panel of antibodies to aid in the differential diagnosis of anaplastic cells of undetermined origin. When used with markers of simple epithelium, it can aid in the differentiation of carcinomas from non epithelial tumors, e.g., gliomas, lymphomas, melanomas, sarcomas or seminomas. Because it does not react with all carcinomas, it may be used also as an aid in the subclassification of carcinomas. It is also useful in the differential diagnosis of small-acinar lesions of the prostate gland because it stains basal cells which are absent in the disease.
- Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34βE12 (Product Code No. M0630) is a mouse anti-human antibody produced as a tissue culture supernatant. The antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, containing fetal calf serum and 15mM sodium azide. (1mL total volume).
- Ready-to-Use Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, clone 34βE12 Antibody and Negative Control (Product Code No. N1553) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing fetal calf serum and 15mM sodium azide (7mL total volume). The primary antibody is packaged with a negative control reagent consisting of fetal calf serum in 0.05M Tris-HCl buffer, pH 7.6 and 15mM sodium azide (5mL total volume).
Here's an analysis of the acceptance criteria and supporting study for the DAKO® Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34βE12 Monoclonal Antibody (K971905), based on the provided text:
Summary of Acceptance Criteria and Device Performance (Reproducibility Study)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reproducibility | Consistent results with intra-run testing. Consistent results with inter-run testing. |
| Normal Tissue Staining (Positive) | Stained breast, cervix, esophagus, prostate, salivary gland, skin, thymus, and tonsil. |
| Normal Tissue Staining (Negative) | Did not stain adrenal, bone marrow, brain (cerebellum and cerebrum), colon, heart, kidney, liver, lung, mesothelial cells, ovary, pancreas, parathyroid, pericardium, peripheral nerve, pituitary, skeletal muscle, small intestine, spleen, stomach, testis, thyroid, and uterus. |
Study Details:
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Sample Size and Data Provenance for Test Set:
- Reproducibility Testing: Eight serial sections from each of three different formalin-fixed, paraffin-embedded blocks of normal skin were used. (Total: 24 sections for staining, plus 3 negative control slides per test day).
- Normal Tissue Testing: A "required panel of normal tissues" was tested. The exact number of tissue samples for each type is not specified but includes 22 different normal tissue types.
- Data Provenance: The text does not explicitly state the country of origin. The tissues were formalin-fixed and paraffin-embedded, suggesting retrospective collection typical for pathology labs.
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Number of Experts and Qualifications for Ground Truth (Test Set):
- The document implies that the "Normal Tissue Testing" and "Reproducibility Testing" were observed and evaluated based on expected staining patterns. It does not explicitly state the number or qualifications of experts who established the ground truth for the test set specifically. However, the "Intended Use" section mentions that "Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual," which suggests reliance on general pathology expertise for interpretation of staining results.
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Adjudication Method for Test Set:
- "None" explicitly described. The reproducibility section mentions "consistent results," which implies agreement, but no formal adjudication process (e.g., 2+1, 3+1) is detailed. The assessment of normal tissue staining would typically be performed by a single pathologist or a pathology team without a specific adjudication mentioned in the submission.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done or mentioned. This device is a diagnostic reagent (antibody) for immunohistochemistry, not an AI-assisted diagnostic tool for which such studies are typically performed.
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Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Not applicable. This device is a monoclonal antibody used in a laboratory setting by trained personnel; it is not an algorithm, and its performance is inherently human-dependent for interpretation.
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Type of Ground Truth Used:
- Expected Immunoreactivity/Histological Norms: For normal tissue staining, the ground truth is based on established scientific knowledge of cytokeratin expression in different normal human tissues (i.e., what should stain positive and what should not).
- Reproducibility Study: The ground truth for reproducibility is the expectation that consistent staining patterns will be observed across repeated tests of the same tissue.
- Published Immunoreactivity: This section extensively cites published literature (12 articles) to support the understanding of the antibody's reactivity with various normal and neoplastic tissues. This scientific literature serves as a form of expert consensus and outcomes data on cytokeratin expression.
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Sample Size for Training Set:
- Not applicable as this is not an AI/machine learning device. The design and validation of the antibody are based on biological and chemical principles, not data-driven training sets in the computational sense.
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How Ground Truth for Training Set was Established:
- Not applicable. The "training" for an antibody's performance comes from its biochemical characterization and the vast body of scientific knowledge regarding cytokeratin biology and immunohistochemistry, as summarized in the "Published Immunoreactivity" section and established histological norms.
§ 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).