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Ready-to-Use Format

Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells.

PR (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Concentrated Liquid Antibody Format.

Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.

PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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's clinical history and other diagnostic tests by a qualified pathologist.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for the BOND™ Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Concentrated Liquid Mouse Monoclonal Antibody (Novocastra™) does not contain any information about a study proving the device meets acceptance criteria.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices for its intended use. It outlines the regulatory classification, product code, and general controls applicable to the device. The "Indications for Use" section describes what the antibody is intended for (qualitative identification of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining as an aid in the management, prognosis, and prediction of therapy outcome of breast cancer).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study design (sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance).
• Information on ground truth establishment for test or training sets.
• Training set sample size.

This type of detailed study information is typically found in the applicant's 510(k) submission document itself, which is often much more extensive and not usually fully released in the public "summary" letter. The FDA clearance letter primarily confirms the regulatory status and substantial equivalence determination based on the submitted data, but it doesn't present the raw study data or acceptance criteria in the format requested.

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Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.

Estrogen Receptor Clone 6F11 is indicated as an aid in the management, prognosis and predication of therapy outcome of breast cancer. 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.

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ and the Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ are optimized for use on the Leica Biosystems Bond III staining platform using the Bond Polymer Refine Detection Kit.

Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.

This document is a 510(k) premarket notification decision letter for the Estrogen Receptor Clone 6F11 (ER 6F11) immunohistochemistry reagent. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter primarily states that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the content of this document.

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Ready-to-Use Format: Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BONDMAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells. PR (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Concentrated Liquid Antibody Format: Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. PGR Clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

Not Found

I apologize, but the document you provided does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or the type of ground truth used.

The document is a 510(k) premarket notification letter from the FDA to Leica Biosystems, Inc. regarding their BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16. It focuses on:

• FDA's substantial equivalence determination: Stating the device is substantially equivalent to legally marketed predicate devices.
• Regulatory information: Listing regulation numbers, names, and class.
• General controls and additional controls: Informing the manufacturer about applicable FDA regulations.
• Indications for Use: Describing the intended use of the devices for qualitative identification of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining, primarily as an aid in breast cancer management, prognosis, and prediction of therapy outcome.

To provide the information you requested, I would need a different document, such as a study report, clinical trial summary, or a more detailed technical submission that includes performance data and methodology.

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