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510(k) Data Aggregation

    K Number
    K022767
    Device Name
    RAICHEM LIPID CALIBRATOR
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-09-03

    (13 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAICHEM LIPID CALIBRATOR

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

    The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to an FDA 510(k) premarket notification for a medical device called "RAICHEM® LIPID Calibrator." This document is a clearance letter and does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria.

    The information you've requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in the 510(k) submission itself, or in supporting validation studies referenced within the submission, not in the FDA's clearance letter.

    The clearance letter primarily states that the FDA has reviewed the submission (K022767) and determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use (calibration of Raichem LDL and HDL Cholesterol Direct assay).

    Therefore, based solely on the provided text, I cannot fulfill your request for details on acceptance criteria and study data.

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