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510(k) Data Aggregation

    K Number
    K050790
    Device Name
    SPOTCHEM II LDH TEST
    Manufacturer
    ARKRAY, INC.
    Date Cleared
    2005-06-06

    (70 days)

    Product Code
    CFH
    Regulation Number
    862.1440
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPOTCHEM II LDH TEST

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

    The SPOTCHEM II LDH test is intended to measure the activity of the enzyme lactate dehydrogenase in serum, plasma, and whole blood. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) substantial equivalence letter from the FDA for a medical device (Arkray SPOTCHEM II LDH test). It does not contain any information about acceptance criteria, device performance details, specifics of a study, sample sizes, expert qualifications, or ground truth establishment relevant to the listed questions.

    This document is a regulatory approval letter, not a scientific study report or a summary of performance data. Therefore, I cannot extract the requested information from the given text.

    To answer your questions, I would need a different type of document, such as:

    • A clinical study report
    • A performance evaluation report
    • A detailed 510(k) submission document (beyond just the decision letter)
    • A scientific publication describing the device's validation.
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