Search Filters

Search Results

Found 13 results

510(k) Data Aggregation

    K Number
    K193393
    Device Name
    BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
    Manufacturer
    Leica Biosystems Newcastle Ltd.
    Date Cleared
    2020-03-06

    (91 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ready-to-Use Format For in vitro diagnostic use. BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells. Progesterone Receptor 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. Progesterone Receptor Clone (16) is optimized for use on the Leica Biosystems automated BOND-MAX or BOND-III systems using the BOND Polymer Refine Detection kit. Concentrated Liquid Antibody Format For in vitro diagnostic use. Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format) 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. Progesterone Receptor Clone (10) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells. Progesterone Receptor Clone (16) Monoclonal Antibody (Concentrated Liquid Antibody Format) 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.
    Device Description
    Progesterone Receptor (16) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. This antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify Progesterone Receptor expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination. Progesterone Receptor (PGR) Clone 16 Primary Antibody is provided in a Ready-to-Use (RTU) and a concentrated liquid format. The RTU format is supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative and is provided in two volumes (7 mL and 30 mL). The total protein concentration is approximately 10 mg/mL and the total antibody concentration is greater than or equal to 1 mg/L as determined by ELISA. The RTU format is optimally diluted for use on the automated BOND-MAX and BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). The concentrated liquid format is provided so that customers may utilize manual staining protocols. The concentrated liquid format is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. The total protein concentration is determined on a per batch basis and is described on the vial label, and the antibody concentration is greater than or equal to 324.0 mg/L as determined by ELISA. The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).
    Ask a Question
    K Number
    K183102
    Device Name
    BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
    Manufacturer
    Leica Biosystems Newcastle Limited
    Date Cleared
    2018-12-07

    (30 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    Not Found
    Ask a Question
    K Number
    K170005
    Device Name
    FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
    Manufacturer
    DAKO DENMARK A/S
    Date Cleared
    2017-12-21

    (352 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the En Vision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds progesterone receptor-expressing cells and is useful in the assessment of progesterone 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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.
    Device Description
    FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Readyto-Use (Dako Omnis) is utilized to perform a qualitative immunohistochemical (IHC) assay to identify progesterone receptor (PR) expression in formalin fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The proposed device is a variant of FLEX Monoclonal Mouse Anti-Human Progesterone Receptor intended for use with the automated slide staining instrument Dako Omnis. The design of the proposed device is developed to provide equivalent performance to its predicate FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument. The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The proposed device is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.
    Ask a Question
    K Number
    K171753
    Device Name
    BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
    Manufacturer
    Leica Biosystems Newcastle Limited
    Date Cleared
    2017-07-21

    (39 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    Not Found
    Ask a Question
    K Number
    K160922
    Device Name
    FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
    Manufacturer
    Dako North America, Inc.
    Date Cleared
    2016-05-03

    (29 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-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 in formalin-fixed, paraffin-embedded 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. For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link), is intended for use in immunohistochemistry together with EnVision FLEX+, High pH visualization kit together with Autostainer Link 48 instrument to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded human breast carcinoma. This antibody labels progesterone receptor-positive cells and is useful in the assessment of progesterone 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.
    Device Description
    Not Found
    Ask a Question
    K Number
    K130861
    Device Name
    MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
    Manufacturer
    DAKO NORTH AMERICA, INC.
    Date Cleared
    2013-12-09

    (256 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use. FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (LINK) is intended for use in immunohistochemistry with EnVision™ FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma. This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone 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.
    Device Description
    Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is utilized to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma. This product is pre-diluted and optimized for use with the Dako Autostainer Link 48 automated slide staining platform. Anti-PR, Clone PgR 636 is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The target concentration of Anti-PR, Clone PgR 636 is 0.5 ug/mL; the acceptable concentration range is 0.4 ug/mL to 0.6 ug/mL.
    Ask a Question
    K Number
    K103818
    Device Name
    CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
    Manufacturer
    VENTANA MEDICAL SYTEMS, INC
    Date Cleared
    2011-11-16

    (322 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This antibody is intended for in vitro diagnostic (IVD) use. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal (IgG) Primary Antibody is intended for laboratory use for the qualitative detection of progesterone receptor (PR) antigen in sections of formalin-fixed, paraffin-embedded tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-PR (1E2) is directed against an epitope present on human progesterone receptor protein located in the nucleus of PR positive normal and neoplastic cells. CONFIRM anti-PR (1E2) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. Prescription use only.
    Device Description
    Ventana's CONFIRM anti-Progesterone Receptor (1E2) Rabbit Monoclonal Primary Antibody specifically binds to progesterone receptor antigen located in the nuclear region of a variety of normal and neoplastic tissues. The antibody is diluted in 0.05 M Tris-HCl with 2% carrier protein, and 0.1% ProClin 300, a preservative. There is trace (0.2%) fetal calf serum of U.S. origin from the stock solution. Total protein concentration of the reagent is approximately 10 mg/mL. Specific antibody concentration is approximately 1 µg/mL. CONFIRM anti-PR (1E2) is a rabbit monoclonal antibody produced as a cell culture supernatant.
    Ask a Question
    K Number
    K062615
    Device Name
    VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
    Manufacturer
    VISION BIOSYSTEMS INC.
    Date Cleared
    2007-01-29

    (146 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vision BioSystems Progesterone Receptor Clone 16 (PGR Clone 16) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, progesterone receptor (PGR) antigen in sections of formalin fixed, paraffin embedded tissue. 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. Novocastra™ antibodies are intended for manual use. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Defection Kits. Bond™ Ready-to-Use Primary Antibodies are optimized for use on the Vision BioSystems Bond-max™ system.
    Device Description
    PGR Clone 16 is a monoclonal mouse antibody that detects a human progesterone receptor epitope located in the nucleus of PGR positive cells.
    Ask a Question
    K Number
    K060462
    Device Name
    NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)
    Manufacturer
    LAB VISION CORP.
    Date Cleared
    2006-04-24

    (61 days)

    Product Code
    MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeoMarkers Rabbit Monoclonal anti-Human PR Antibody (Clone SP2) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
    Device Description
    Immunohistochemistry Assay, Antibody, Progesterone Receptor. Antibody for detection of progesterone receptor in histological tissue sections. NeoMarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)
    Ask a Question
    K Number
    K042884
    Device Name
    DAKOCYTOMATION ER/PR PHARMDX KIT
    Manufacturer
    DAKOCYTOMATION CALIFORNIA, INC.
    Date Cleared
    2005-02-15

    (119 days)

    Product Code
    MXZ, MYA
    Regulation Number
    864.1860
    Why did this record match?
    Product Code :

    MXZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DakoCytomation ER/PR pharmDx™ assay is an immunohistochemical (IHC) kit system to identify human estrogen receptor (ER) and human progesterone receptor (PR) expression in breast cancer tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR located in the cell nucleus of ER and/or PR-expressing cells. ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with antihormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer. The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffinembedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. 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
    Device Description
    The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological expressing cells respectively. ER/PR pharmDx assay is available in two configurations, both manual and automated and is optimized for use with DakoCytomation detection systems. The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is a component of the ER/PR pharmDx kit, which will also be commercially available as a concentrate.
    Ask a Question

    Page 1 of 2