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510(k) Data Aggregation

    K Number
    K091991
    Device Name
    EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2009-09-04

    (64 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EasyRA direct bilirubin reagent is intended for the quantitative determination of Direct Bilirubin (DBIL) in the human serum of adults, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in-vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification for the EasyRA Direct-Bilirubin Reagent, which is an in vitro diagnostic device. The provided text does not include the acceptance criteria for the device's performance or the details of the study proving it meets those criteria.

    The 510(k) summary (which would typically contain performance data and acceptance criteria) is not present in the provided document. The current text is limited to the FDA's clearance letter and the device's indications for use.

    Therefore, I cannot extract the requested information. The document focuses on regulatory clearance and provides the following:

    • Device Name: EasyRA Direct-Bilirubin Reagent
    • Regulation Number: 21 CFR §862.1110
    • Regulation Name: Bilirubin (total or direct) test system
    • Product Codes: CIG
    • Indications for Use: Quantitative determination of Direct Bilirubin (DBIL) in human serum of adults, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in-vitro diagnostic use only.

    To answer your request, I would need access to the performance study section of the 510(k) submission, which typically includes analytical and clinical performance data, acceptance criteria, and study methodology.

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