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510(k) Data Aggregation

    K Number
    K991111
    Device Name
    BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (54 days)

    Product Code
    CIC
    Regulation Number
    862.1145
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02

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

    The calcium reagents: Buffer/Chromogen(R1), product No. CA110-01 and EDTA Reagent (R2), product No. CA110-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of calcium in serum, plasma and urine.

    Device Description

    Buffer Chromogen (R1), EDTA Reagent (R2)

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    The document is a 510(k) clearance letter from the FDA for a device named "Buffer Chromogen (R1), EDTA Reagent (R2)" for the quantitative determination of calcium. It primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. It does not contain a study report or details of performance testing.

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