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510(k) Data Aggregation

    K Number
    K991246
    Device Name
    FRUCTOSAMINE, MODEL FR 106-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-12-16

    (248 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRUCTOSAMINE, MODEL FR 106-01

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

    The fructosamine reagent (R1), product No. FR10-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of fructosamine in serum, or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The document provided is a 510(k) clearance letter from the FDA for a Fructosamine reagent, not a study report or technical documentation for a medical device with an algorithm/AI component. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.

    Specifically, the letter:

    • Grants substantial equivalence to a predicate device. This means the device is considered as safe and effective as a legally marketed device, but it does not detail the specific performance metrics or studies conducted by the manufacturer to demonstrate this.
    • Mentions "Indications For Use" but does not provide performance criteria or study results.
    • Does not refer to any AI/algorithm component, human reader performance, or ground truth establishment.

    Therefore, I cannot extract the requested information from this document.

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