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510(k) Data Aggregation

    K Number
    K991109
    Device Name
    CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (54 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The creatinine reagents: Alkaline Diluent(R1), product No. CA105-01 and Piccio Acid ed the second of a CA105-02-are intended for Invitro Diagnostic use in the automated, The creatinine reagents: Alkaline Diluent(R1), product No. CH10507 use in the automated, (R2), product No. CA105-02 are intended for Invitro Diagnosic use in the automated, (R2), product No. CA105-02 are intended for Interest of the

    Device Description

    CREATININE Reagent

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device called "CREATININE Reagent". It outlines the FDA's decision to clear the device for marketing based on substantial equivalence to a predicate device. However, the document does not contain any information regarding the acceptance criteria, study details, performance data, or ground truth establishment for the CREATININE Reagent device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a regulatory approval letter, not a scientific study report.

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