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The BioGenex Mouse Monoclonal Anti-Estrogen Receptor Antibody (Clone ER88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human estrogen receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The ER88 antibody specifically binds to antigens located in the nucleus of cell populations that express estrogen receptor in normal and abnormal tissues. This antibody is indicated as an aid in assessing patient response to hormonal therapy and as an aid in the prognosis and management of breast cancer patients. 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.

BioGenex ER88 is a monoclonal antibody, which specifically binds to estrogen receptor antigen located in the nuclear region of a variety of normal and abnormal tissues. It is a mouse monoclonal anti-estrogen receptor antibody from mouse ascites fluid diluted in phosphate buffered saline pH 7.6 containing bovine serum albumin as carrier protein and 0.09% sodium azide as preservative. The antibody is available in concentrated (MU368-UC) as well as ready to use form (AM368-5M and AM368-10M). Refer to package insert for details.

Here's a breakdown of the acceptance criteria and study detailed in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to existing methods rather than explicit, numerical acceptance criteria for a new AI diagnostic. However, the core performance metric for equivalency is the concordance between the new IHC assay and the established DCC assay.

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