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    K Number
    K031208
    Device Name
    REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
    Manufacturer
    CORGENIX, INC.
    Date Cleared
    2003-07-07

    (81 days)

    Product Code
    MSV,DHC
    Regulation Number
    866.5660
    Type
    Special
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The REAADS IgM Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    The REAADS IgG Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic test kits. It does not contain information about acceptance criteria or specific study details that prove the device meets acceptance criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices and thus can be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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