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510(k) Data Aggregation

    K Number
    K242492

    Validate with FDA (Live)

    Device Name
    Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
    Manufacturer
    Techno-Path Manufacturing , Ltd.
    Date Cleared
    2025-12-30

    (496 days)

    Product Code
    QCH
    Regulation Number
    866.3920
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    All
    Reference & Predicate Devices
    K190428
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

    Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

    Device Description

    Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.

    Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).

    AI/ML Overview

    N/A

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