Immunohistochemistry test systems (IHCs) are in vitro diagnostic devices composed of polyclonal or monoclonal antibodies, along with instructions for use and performance claims. These systems may be packaged with additional reagents in kits. Their main purpose is to identify antigens in tissue or cytologic specimens using immunological techniques. Devices meant for use in conjunction with flow cytometry are not classified as IHCs.

The intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens.

Intended Use: Estrogen Receptor Clone 6F11 is a mouse monoclonal antibody used in immunohistochemistry to identify estrogen receptor antigens in breast cancer tissue, specifically in the nucleus of ER-positive cells.

Device Description: Estrogen Receptor Clone 61F11 is a mouse anti-human monoclonal antibody used in semi-quantitative immunohistochemical assays to identify estrogen receptor expression in human breast cancer tissue. Available in two formats, it is optimally diluted for use on Bond Ill and Bond Polymer Refine Detection kit. The antibody has a total protein concentration of 3.8 g/L and an immunoglobulin concentration of 75 mg/I.

Intended Use: The System is an automated digital slide creation, management, viewing, and analysis system for in vitro diagnostic use. It aids pathologists in detecting, counting, and classifying tissues and cells based on colour, intensity, size, pattern, and shape. The IHC HER2 Breast Tissue Tunable Image Analysis application is used for detecting and measuring HER2/neu in normal and neoplastic tissue. The accuracy of test results depends on the quality of immunohistochemical staining.

Device Description: The System includes a digital microscope, slide scanner, computer, colour monitor, keyboard, digital pathology information management software, and image analysis software. It aids pathologists in the quantitative assessment of immunohistochemistry-stained histological specimens for human epidermal growth factor Receptor 2 (HER2) using a tuneable algorithm based on 20 training slides.

Intended Use: The System is an automated digital slide creation, management, viewing, and analysis system for in vitro diagnostic use. It aids pathologists in detecting, counting, and classifying clinical tissues and cells based on color, intensity, size, pattern, and shape. It is used for ER (estrogen receptor) and PR(progesterone receptor) detection in breast cancer management, prognosis, and therapy outcomes.

Device Description: The system is an automated digital slide creation, management, viewing, and analysis system that includes a digital microscope slide scanner, computer, color monitor, keyboard, digital pathology information management software, and image analysis software. It aids pathologists in quantitatively assessing immunohistochemistry-stained histological specimens.

Intended Use: This laboratory tool uses immunohistochemistry to identify the p63 antigen in prostate tissue from biopsy or surgical procedures. The presence or absence of p63 staining aids pathologists in differential diagnosis of prostate cancer, alongside morphological findings.

Device Description: The reagent is available in two configurations: reagent only or reagent with buffer for antigen retrieval methods. The antibody is concentrated within a buffer, and other reagents and equipment are required but not supplied with the reagent.

Intended Use: It is intended for in vitro diagnostic use to aid the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern, and shape.

Device Description: The system consists of an automated digital microscope slide scanner, operation monitor, keyboard, and digital pathology information management software. It digitizes microscope slides, stores and manages images, retrieves and displays them, supports remote access, annotates slides, and edits metadata. It also allows pathologists to read digital slides on a viewing monitor, enabling clinically relevant decisions.

Intended Use: It is intended for laboratory use to control semi-quantitative immunohistochemistry using different Her2/neu antibodies. This control ensures that the performance of immunohistochemical staining is consistent in one laboratory over time and also aids in correlation with the results of other laboratories.

Device Description: This product provides appropriate control for semi-quantitative immunohistochemistry using polyclonal or monoclonal HER2/neu antibodies. Each slide contains four control sections prepared for breast cancer cell lines that represent different levels of Her-2heu protein expression (-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-embedded, and the slide is positively charged. It is a prescription-use device.

• Precision/Reproducibility
• Detection studies
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay

The same is applicable for CE Marking under IVDR also.

Mandatory for 510k submission and IVDR CE Marking