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510(k) Data Aggregation

    K Number
    K051072
    Device Name
    BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Date Cleared
    2005-05-12

    (16 days)

    Product Code
    GKA
    Regulation Number
    864.7415
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K924813
    Why did this record match?
    Device Name :

    BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

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

    The Bio-Rad VARIANTnbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high performance liquid chromatography (HPLC).

    The Bio-Rad VARIANTnbs Sickle Cell Program is intended for Professional Use Only. For In Vitro Diagnostic Use.

    The Bio-Rad VARIANTnbs Sickle Cell Program is for use only with the Bio-Rad VARIANTnbs Newborn Screening System.

    Device Description

    The VARIANTnbs Newborn Screening System is a High Performance Liquid Chromatography (HPLC) System consisting of an auto sampler for microwell plates (VARIANTnbs Neonatal Auto Sampler) and a chromatography station (VARIANTnbs Chromatography Station). The VARIANTnbs Sickle Cell Program consists of an analytical cartridge containing cation exchange resin and two (2) buffers for establishing a gradient. The Genetic Data Management (GDM) software is designed to operate the VARIANTnbs Newborn Screening System for the purposes of qualitatively screening for the presence of normal hemoglobins F and A and abnormal hemoglobins S, D, C and E in eluates of discs punched from neonatal heel stick blood collected on filter paper or of one aspirated directly from microwell plates with the filter paper disc still present, collected in a sample loop and then injected into the flow path of the chromatography module. The hemoglobins are bound on the analytical cartridge in the presence of Elution Buffer 1. The ionic strength is subsequently raised by adding increasing amounts of Elution Buffer 2. The program is designed to have the hemoglobins of interest elute from the cartridge with retention times that fall within pre-determined windows characteristic of known hemoglobins. Eluted hemoglobins are detected with a dual-wavelength filter photometer which monitors hemoglobin absorbance at 415 mm and corrects for any gradient induced absorbance changes at 690 nm. Processed data is output in a printed report that contains 1) sample identification, 2) date and time of analysis, 3) a peak table containing observed peak name(s), retention time(s), peak height(s), peak area(s), and relative area percent(s), 4) total chromatogram area, 5) chromatogram and 6) any error message(s). Also reported is an optional "pattern assignment" based upon "pattern rules" derived from literature.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Predicate Device)Reported Device Performance (New Device)
    CorrelationNot explicitly defined, but implied by substantial equivalence to K924813.High agreement with predicate device: 590/591 (FA), 52/52 (FAE), 37/38 (FAD), 247/247 (FAS), 90/90 (FAC), 3/3 (FSC), 2/2 (FC), 1/1 (FE), 1/1 (F).
    Precision (Retention Time, within-run)Peak retention time precision
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