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For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.

The provided text is a 510(k) Pre-Market Notification for a medical device, specifically the Dako Anti-Human ER $\alpha$ Clone EP1. It describes the device, its intended use, and claims substantial equivalence to a predicate device, but does not contain typical acceptance criteria or a detailed study section with performance metrics like sensitivity, specificity, or concordance rates against a ground truth.

Instead, it states: "Performance characteristics evaluated in support of the Dako Anti-Human ER $\alpha$, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above." However, the actual results of these tests are not present in this document.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, or expert details because this information is not included in the provided text.

The document only states that such studies were performed and showed "substantial equivalency" to the predicate device (ER $\alpha$ component of the Dako ER/PR pharmDx™ Kit, K042884).

If this were a typical AI/ML device submission, a dedicated section detailing these performance characteristics would be expected. Since this is an Immunohistochemistry (IHC) reagent, the performance evaluation methods might differ from those for an image-based AI device.

Without the actual performance data from the specific studies mentioned, I cannot complete the requested information.

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