LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020467
    Device Name
    SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-03-29

    (45 days)

    Product Code
    CFE
    Regulation Number
    862.1445
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

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

    The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.

    The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.

    Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry. I cannot answer your question. The document does not contain the information requested in your query. The document is an FDA 510(k) clearance letter for the "SPIFE LD Vis Isoenzyme Kit" and primarily discusses the regulatory approval, classification, and indications for use of the device. It does not provide details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance evaluation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1