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510(k) Data Aggregation

    K Number
    K060027
    Device Name
    ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
    Manufacturer
    BIOKIT S.A.
    Date Cleared
    2006-01-26

    (22 days)

    Product Code
    JJX,JIT
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Calibrators: The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
    Controls: ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
    For in vitro diagnostic use.

    Device Description

    Calibrators: The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
    Controls: The ARCHITECT ® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma.

    AI/ML Overview

    The provided document, K060027, is a 510(k) summary for the ARCHITECT® DHEA-S Calibrators and Controls. It describes the devices and claims substantial equivalence to a legally marketed predicate device (DPC IMMULITE® DHEA-SO4). However, it does not contain the acceptance criteria or a study demonstrating that the device meets specific performance criteria.

    Instead, the submission focuses on comparing the new device's technological characteristics (intended use, methodology, assay protocols, matrix) to the predicate device to demonstrate substantial equivalence. It also lists differences such as the platform, traceability, standardization, calibration range/levels, and value assignment.

    The FDA's response confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical performance data against specific acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document does not include such information.

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