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510(k) Data Aggregation

    K Number
    K040923
    Device Name
    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
    Manufacturer
    IBL GMBH
    Date Cleared
    2004-07-22

    (105 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.
    Device Description
    Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
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    K Number
    K973898
    Device Name
    PROGESTERONE ELISA
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (30 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
    Device Description
    Not Found
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    K Number
    K972133
    Device Name
    VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
    Manufacturer
    JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
    Date Cleared
    1997-06-24

    (18 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITROS Progesterone Reagent Pack - For the in vitro quantitative measurement of progesterone in human serum and plasma (EDTA or heparin) in the diagnosis and treatment of disorders of the ovaries or placenta VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum or plasma in the diagnosis and treatment of disorders of the ovaries or placenta
    Device Description
    Not Found
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    K Number
    K971725
    Device Name
    OPUS PROGESTERONE
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1997-06-18

    (40 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in human serum or heparanized plasma. OPUS Progesterone is intended for use with the OPUS analyzers. OPUS Progesterone is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of progesterone in serum or heparanized plasma, used in the diagnosis and treatment of disorders of the ovaries or placenta. OPUS Progesterone is intended for use with the OPUS analyzers.
    Device Description
    OPUS Progesterone is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of progesterone in human serum or heparanized plasma.
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    K Number
    K964841
    Device Name
    ELECSYS PROGESTERONE ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-03-24

    (111 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma.
    Device Description
    Competition principle. Total duration of assay: 18 minutes (37 °C). · Ist incubation (9 min.): 50 uL sample - in the presence of a progesterone-derivative labeled with a ruthenium complex(65 uL)** are incubated with Danazol to release progesterone. After addition of biotinylated polyclonal ·2nd incubation (9 min.): progesterone-specific antibodies (50 uL) and streptavidin-coated microparticles (50 uL), progesterone from the sample competes with the labeled progesterone derivative for the antibody binding sites. At the same time the entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. The proportion of labeled progesterone derivative bound to the solid phase is inversely proportional to the progesterone content of the sample. · The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). ·Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. **Tris(2,2'-bipyridy))ruthenium(II) complex (Ru(bpy)2+3)
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    K Number
    K965084
    Device Name
    VIDAS PROESTERONE (PRG) (30 409)
    Manufacturer
    BIOMERIEUX, INC.
    Date Cleared
    1997-01-09

    (21 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIDAS Progesterone (PRG) assay is intended for use with a Vitek ImmunoDiagnostic Assay Systems (VIDAS) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantit determination of progesterone in serum or plasma. The VIDAS Progesterone assay is intended for us an aid in the diagnosis and treatment of disorders of the overies and placenta.
    Device Description
    The VIDAS Progesterone (PRG) assay is an enzyme-linked fluorescent immunoassay (ELFA) that is performed in an automated VIDAS instrument. All assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as a solid phase for the assay as well as a pipetting device. At the time of manufacture, the SPR is coated with mouse anti-progesterone antibodies. Reagents for the assay are located in the sealed Reagent Strips. The sample is transferred into the well containing a progesterone derivative conjugated with alkaline phosphatase. Wash steps remove unbound conjugate. A fluorescent substrate, 4-methylumbellifory! phosphate, is cycled through the SPR and flouresences. The intensity of fluorescence is measured by the optical scanner in the instrument; it is inversely proportional to the progesterone concentration present in the sample.
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    K Number
    K955025
    Device Name
    AXSYM PROGESTERONE
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1996-03-07

    (126 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA).
    Device Description
    AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA). AxSYM Progesterone is calibrated with Abbott calibrators and Abbott controls are used for verification of the calibration and to monitor the performance of the Abbott AxSYM System.
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    K Number
    K955769
    Device Name
    ACCESS PROGESTERONE ASSAY
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Date Cleared
    1996-02-05

    (46 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Product Code :

    JLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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