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510(k) Data Aggregation

    K Number
    K973995
    Device Name
    RANDOX BILIRUBIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1997-12-08

    (48 days)

    Product Code
    GIG
    Regulation Number
    864.7500
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    GIG

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

    The Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent for the quantitative determination of total and direct bilirubin in human serum and plasma. This method uses diazotized sulphanilic acid to measure bilirubin. To measure total bilirubin the sample is first incubated with caffeine which releases bilirubin from albumin. Direct (conjugate) bilirubin is determined in the absence of caffeine. Measurements of bilirubin are used in the diagnosis of liver disease, in the detection of haemolytic anaemia and to evaluate jaundice.

    Device Description

    The Randox Laboratories Limited Bilirubin Test Kit is an in vitro diagnostic reagent.

    AI/ML Overview

    I apologize, but this document does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Randox Bilirubin Test Kit, including its intended use. It does not detail specific acceptance criteria, study design, or performance results.

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