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510(k) Data Aggregation

    K Number
    K082141
    Device Name
    ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
    Manufacturer
    BIOKIT S.A.
    Date Cleared
    2008-09-03

    (35 days)

    Product Code
    JIT,JJX
    Regulation Number
    862.1150
    Type
    Abbreviated
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K021532,K030452
    Why did this record match?
    Device Name :

    ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

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

    The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

    The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.

    For in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for the ARCHITECT C-Peptide Calibrators and Controls. It describes the intended use and states substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

    Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document is a regulatory approval notification, not a performance study report.

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