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510(k) Data Aggregation

    K Number
    K240800
    Device Name
    Access Intrinsic Factor Ab
    Manufacturer
    Beckman Coulter Inc
    Date Cleared
    2024-05-03

    (39 days)

    Product Code
    LIG
    Regulation Number
    862.1810
    Why did this record match?
    Product Code :

    LIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
    Device Description
    The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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    K Number
    K071346
    Device Name
    IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2007-09-24

    (133 days)

    Product Code
    LIG
    Regulation Number
    862.1810
    Why did this record match?
    Product Code :

    LIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.
    Device Description
    An enzyme linked immunoassay (ELISA)
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    K Number
    K061841
    Device Name
    QUANTA LITE INTRINSIC FACTOR ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2006-12-22

    (176 days)

    Product Code
    LIG
    Regulation Number
    862.1810
    Why did this record match?
    Product Code :

    LIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.
    Device Description
    Not Found
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    K Number
    K033603
    Device Name
    INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2003-12-19

    (32 days)

    Product Code
    LIG, JIT, JJX
    Regulation Number
    862.1810
    Why did this record match?
    Product Code :

    LIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
    Device Description
    The Access Intrinsic Factor Ab reagents, calibrators, QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the detection of intrinsic factor antibody in human serum and plasma.
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    K Number
    K993251
    Device Name
    IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1999-11-17

    (50 days)

    Product Code
    LIG
    Regulation Number
    862.1810
    Why did this record match?
    Product Code :

    LIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMMULITE 2000 Vitamin B12 is for in vitro diagnostic use with the IMMULITE 2000 Analyzer for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
    Device Description
    IMMULITE® 2000 Vitamin B12 is a clinical device for use with the IMMULITE 2000 Automated Immunoassay Analyzer. IMMULITE® and IMMULITE® 2000 Vitamin B12 are chemiluminescent immunoassays. The technology in DPC's IMMULITE® 2000 Vitamin B12 is a unique combination of technologies employed in previously cleared and commercially marketed DPC products. The IMMULITE 2000 Vitamin B12 assay begins with a one-cycle sample treatment of patient serum or plasma with dithiothreitol (DTT) and a sodium hydroxide/potassium cyanide solution (NaOH/KCN) in a reaction tube containing no bead. After a 30-minute incubation, the treated sample is transferred to a second reaction tube containing a vitamin B12-coated polystyrene bead, hog intrinsic factor (HIF) and an alkaline phosphatase-labeled antibody specific for HIF. During a 30-minute incubation, the vitamin B12 released from endogenous binding proteins during sample treatment competes with immobilized vitamin B12 for binding with HIF. Alkaline phosphatase-labeled anti-HIF antibody binds to HIF and is immobilized only if HIF is bound to the B12-coated bead. Unbound enzyme conjugate is removed by centrifugal wash. Substrate is added. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound comblex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of vitamin B12 in the sample.
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    K Number
    K984108
    Device Name
    ABBOTT ARCHITECT B12
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1999-02-03

    (78 days)

    Product Code
    LIG
    Regulation Number
    862.1810
    Why did this record match?
    Product Code :

    LIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
    Device Description
    The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
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