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510(k) Data Aggregation

    K Number
    K001607
    Device Name
    REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
    Manufacturer
    REPROMEDIX CORP.
    Date Cleared
    2000-10-05

    (134 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991692
    Device Name
    CHIRON DIAGNOSTICS ACS: 180 FT3
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Date Cleared
    1999-06-18

    (31 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of free triiodothyronine (FT3) in serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. Measurements obtained by this test are used in the diagnosis and treatment of thyroid diseases.
    Device Description
    Trilodothyronine (3,5,3'-L-triiodothyronine, T3) is a hormone synthesized and secreted from the thyroid gland, and formed by peripheral deiodination of thyroxine (T4). T3 and T4 are secreted into the circulation in response to thyroid stimulating hormone (TSH) and play an important role in requlating metabolism In the circulation, 99.7% of T3 is reversibly bound to transport proteins, primarily thyroxinebinding globulin (TBG) and to a lesser extent albumin and prealbumin. The remaining T3 does not bind to transport proteins, but is free in the circulation. This unbound fraction of the total T3 concentration is free triiodothyronine (free T3, FT3). Unbound T3 is metabolically active. Free T3 levels correlate with T3 secretion and metabolism. In hypothyroidism and hyperthyroidism, free T3 levels parallel changes in total T3 levels. However, measuring free T3 is useful when altered levels of total T3 occur due to changes in T3 binding proteins, especially TBG. TBG levels remain relatively constant in healthy individuals, but certain conditions such as normal pregnancy and steroid therapy can alter these levels. In these conditions, free T3 levels are unchanged, while total T3 levels parallel the changes in TBG. The Chiron Diagnostics ACS:180 FT3 assay is a competitive immunoassay using direct, chemiluminescent technology. FT3 in the sample competes with a T3 analog, which is covalently coupled to paramagnetic particles in the Solid Phase, for a limited amount of a combination of acridinium ester-labeled monoclonal mouse anti-T3 antibodies in the Lite Reagent. The system automatically performs the following steps: - dispenses 50 µL of sample into a cuvette ● - dispenses 100 µL of Lite Reagent and incubates for 5.0 minutes at 37 C ● - dispenses 450 µL of Solid Phase and incubates for 2.5 minutes at 37 C . - separates, aspirates, and washes the cuvettes with reagent water ● - dispenses 300 µL each of Reagent 1 and Reagent 2 to initiate the chemiluminescent . reaction - . reports the results according to the selected option, as described in the system operating instructions or in the online help system An inverse relationship exists between the amount of FT3 present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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    K Number
    K991311
    Device Name
    TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-06-02

    (47 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioCheck Total T3 EIA is intended for the quantitative determination of triiodothyronine (T3) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
    Device Description
    Not Found
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    K Number
    K991252
    Device Name
    AIA-PACK FT3 ASSAY
    Manufacturer
    TOSOH MEDICS, INC.
    Date Cleared
    1999-05-11

    (28 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
    Device Description
    Not Found
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    K Number
    K981824
    Device Name
    OPTICOAT T3 EIA KIT
    Manufacturer
    BIOTECX LABORATORIES, INC.
    Date Cleared
    1998-12-22

    (214 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
    Device Description
    Not Found
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    K Number
    K983434
    Device Name
    ABBOTT ARCHITECT TOTAL T3
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-11-20

    (52 days)

    Product Code
    CDP, JIT, JJX
    Regulation Number
    862.1710
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    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T, assay is to be used as an aid in the assessment of thyroid status.
    Device Description
    ARCHITECT Total T2 is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Total T, is calibrated with ARCHITECT Total T. Calibrators. ARCHITECT Total T2 Controls are assayed for verification of the accuracy and precision of the Abbott ARCHITECT i System.
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    K Number
    K983439
    Device Name
    ABBOTT ARCHITECT FREE T3
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-11-20

    (52 days)

    Product Code
    CDP, JIT, JJX
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARCHITECT™ Free Ts (FT2) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T3) in human serum and plasma. The ARCHITECT Free T3 assay is to be used as an aid in the assessment of thyroid status.
    Device Description
    ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T2 is calibrated with ARCHITECT Free T2 Calibrators. ARCHITECT Free T2 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
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    K Number
    K974027
    Device Name
    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
    Manufacturer
    ALFA BIOTECH (UK) LTD.
    Date Cleared
    1998-02-02

    (102 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.
    Device Description
    Fluorescent immunoassay reagents.
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    K Number
    K974634
    Device Name
    IMMULITE FREE T3
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1998-01-02

    (21 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DPC's IMMULITE® Free T3 is a chemiluminescent assay for use with the IMMULITE® Automated Immunoassay Analyzer and is designed for the quantitative measurement of Free T3 in serum. It is intended strictly for in vitro diagnostic use as an aid in clinical assessment of thyroid status.
    Device Description
    Free T3 is a solid-phase, IMMULITE® Chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Immunoassay Analyzer.
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    K Number
    K973966
    Device Name
    ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-10-31

    (14 days)

    Product Code
    CDP, JIS
    Regulation Number
    862.1710
    Why did this record match?
    Product Code :

    CDP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACCESS® Total T3 Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of triiodothyronine levels in human serum, using the ACCESS® Immunoassay System. The clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto's thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.
    Device Description
    The ACCESS® Total T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of triiodothyronine in human serum.
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