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510(k) Data Aggregation

    K Number
    K000483
    Device Name
    RANDOX ALBUMIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2000-03-31

    (46 days)

    Product Code
    CJW
    Regulation Number
    862.1035
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RANDOX ALBUMIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K984494
    Device Name
    RANDOX ALBUMIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1999-03-23

    (96 days)

    Product Code
    CIX
    Regulation Number
    862.1035
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RANDOX ALBUMIN

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

    The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm. Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia due to liver disease, kidney disease, malnutrition or malabsorption and burns or dermatitis.

    Device Description

    The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Randox Albumin". This document primarily focuses on the regulatory approval, classification, and indications for use of the device.

    It does not contain any information regarding acceptance criteria for a study, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC).

    Therefore, I cannot extract the requested information from the given text.

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