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510(k) Data Aggregation

    K Number
    K972761
    Device Name
    SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
    Manufacturer
    SEALITE SCIENCES, INC.
    Date Cleared
    1997-09-25

    (63 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use.
    Device Description
    The AquaLite® hGH Bioluminescent Immunoassay Kit uses a mouse monoclonal anti-hGH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples or appropriate calibrators or controls, are pipetted (150 uL) into the precoated tubes. A sheep anti-hGH antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. hGH in the sample combines with the antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 120-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate. The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the hGH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the hGH calibrators is plotted against hGH concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to hGH concentration in ng/mL. Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.
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    K Number
    K971353
    Device Name
    DSL ACTIVE NON-EXTRACTION IGF-I ELISA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1997-05-12

    (31 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.
    Device Description
    The DSL Active IGF-1 ELISA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum. This ELISA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the microtitration wells. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the anti-IGF-I antibody conjugated to the enzyme horseradish peroxidase.
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    K Number
    K970701
    Device Name
    DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1997-04-02

    (35 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
    Device Description
    The DSL 1900 hGH IRMA kit was developed for the quantitative measurement of hGH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample.
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    K Number
    K962758
    Device Name
    DSL 9100 IGF-II IRMA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-08-30

    (45 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.
    Device Description
    The DSL 9100 IGF-II IRMA kit was developed for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube, the other antibody, mouse monoclonal anti-IGF-II is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound IGF-II is directly proportional to the concentration of the IGF-II present in the sample.
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    K Number
    K961678
    Device Name
    HUMAN GROWTH HORMONE IMMUNOASSAY KIT
    Manufacturer
    NICHOLS INSTITUTE DIAGNOSTICS
    Date Cleared
    1996-07-08

    (68 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961172
    Device Name
    DSL ACTIVE NON-EXTRACTION IGF-I IRMA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-04-23

    (29 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders.
    Device Description
    The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with lodine-125.
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    K Number
    K960551
    Device Name
    DSL ACTIVE HUMAN GROWTH HORMONE ELISA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-03-06

    (27 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.
    Device Description
    Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme.
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    K Number
    K955376
    Device Name
    IMMULITE HGH
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1996-02-16

    (84 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Why did this record match?
    Product Code :

    CFL

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

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