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510(k) Data Aggregation

    K Number
    K051969
    Device Name
    TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA
    Manufacturer
    IBL GMBH
    Date Cleared
    2005-10-03

    (75 days)

    Product Code
    CHQ
    Regulation Number
    862.1165
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine. The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.
    Device Description
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    K Number
    K041349
    Device Name
    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
    Manufacturer
    IBL GMBH
    Date Cleared
    2004-09-24

    (127 days)

    Product Code
    CHP
    Regulation Number
    862.1260
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.
    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
    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?
    Applicant Name (Manufacturer) :

    IBL GMBH

    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
    K033786
    Device Name
    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
    Manufacturer
    IBL GMBH
    Date Cleared
    2004-02-27

    (85 days)

    Product Code
    JIT, CDZ, JJX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Testosterone Luminescence Immunoassay is intended for the in vitro quantitative measurement of testosterone (a male sex hormone) in saliva and serum. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
    Device Description
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    K Number
    K032796
    Device Name
    IBL C3D-CIC EIA TEST
    Manufacturer
    IBL GMBH
    Date Cleared
    2004-01-13

    (127 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
    Device Description
    semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum.
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    K Number
    K032254
    Device Name
    IBL C1Q-CIC CIA TEST
    Manufacturer
    IBL GMBH
    Date Cleared
    2003-08-29

    (38 days)

    Product Code
    DAK
    Regulation Number
    866.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    IBL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
    Device Description
    Not Found
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