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510(k) Data Aggregation

    K Number
    K003609
    Device Name
    N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
    Manufacturer
    OSTEOMETER BIOTECH A/S
    Date Cleared
    2001-05-16

    (175 days)

    Product Code
    NEO
    Regulation Number
    862.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOMETER BIOTECH A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990843
    Device Name
    SERUM CROSSLAPS ONE STEP ELISA
    Manufacturer
    OSTEOMETER BIOTECH A/S
    Date Cleared
    1999-07-09

    (116 days)

    Product Code
    JMM
    Regulation Number
    862.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOMETER BIOTECH A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serum CrossLaps™ One Step ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption and may be used as an aid in : Monitoring bone resorption changes of A. 1.) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies 2. ) Anti-resorptive therapies in individuals diagnosed with osteopenia; a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal Response (Bone Mineral Density) in postmenopausal woman under going anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
    Device Description
    The Serum CrossLaps™ One Step ELISA kit was developed for the quantitative measurement of Type I Collagen C-Telopeptide (CrossLaps™) in human plasma and serum. The EIA format is a non-competitive binding protein assay. The Serum CrossLaps 114 One Step ELISA is based on two highly specific monoclonal antibodies against the amino acid sequence of EK AHD-B-GGR, where the aspartic acid residue (D) is ß-isomerized. In order to obtain a specific signal in the Serum CrossLaps 114 One Step ELISA, two chains of EK AHD-S-GGR must be cross-linked Standards, control, or unknown serum samples are pipetted into the appropriate microtitre wells coated with streptavidin, followed by application of a mixture of a biotinylated antibody and a peroxidase-conjugated antibody. Then, a complex between CrossLaps 110 antigens, biotinylated antibody and peroxidase-conjugated antibody is generated, and this complex binds to the streptavidin surface via the biotinylated antibody. Following the one-step incubation at room temperature, the wells are emptied and washed. A chromogenic substrate is added and the colour reaction is stopped with sulfuric acid. Finally, the absorbance is measured at 450 nm.
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