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510(k) Data Aggregation

    K Number
    K031101
    Device Name
    RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2003-06-16

    (70 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

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

    The RAICHEM Assayed Control Serum is a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for a device called "RAICHEM® Assayed Control Serum Level 1 & 2".

    This document is a regulatory approval letter and does not contain any information about:

    • Acceptance criteria for a study.
    • The results of any study demonstrating device performance.
    • Details about sample sizes, data provenance, experts, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types for testing or training, or how ground truth was established.

    The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. Its "Indications for Use" are described as "a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays."

    Therefore, I cannot provide the requested information based on the text provided.

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