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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: LBR FDA class 1

    Ldl & Vldl Precipitation, Hdl

    Clinical Chemistry

    View full classification →

    LDL and VLDL precipitation for HDL measurement is a clinical chemistry test method in which low-density and very-low-density lipoproteins are selectively precipitated from serum, allowing high-density lipoprotein cholesterol to be measured in the remaining supernatant. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification needed. The product code is LBR, regulated under 21 CFR 862.1475, in the Clinical Chemistry specialty. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LDLC3 LDL-Cholesterol Gen.3
    DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
    DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
    RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
    VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
    ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    AUTOHDL CHOLESTEROL REAGENT SET
    ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
    VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
    HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
    HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
    BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
    ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
    N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
    TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
    N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
    HDL PRECIPITATING REAGENT
    MAGNETIC HDL CHOLESTEROL TEST
    PBI PLUS HDL PRECIPITATING REAGENT
    HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
    SPINPRO HDL PRECIPITATING REAGENT
    SPINPRO HDL PRECIPITATING REAGENT
    INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
    HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
    SYNERMED HDL CHOLESTLEROL REAGENT KIT
    IL TEST(TM) HDL CHOLESTEROL
    HIGH DENSITY LIPOPROTEIN CHOLESTEROL
    MAGNETIC HDL CHOLESTEROL TEST
    HDL CHOLESTEROL REAGENT
    ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
    HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
    BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
    STAT TEST HDL/CHOLESTEROL TEST KIT
    REFLOTRON HDL CHOLESTEROL TEST TABS
    COULTER HDL - CHOLESTEROL REAGENT
    ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
    HDL SINGLES
    HDL PRECIPITATING REAGENT
    HDL CHOLESTEROL REAGENT
    STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
    HDL CHOLESTEROL REAGENT (PTA/MGCL2)
    HDL CHOLESTEROL TEST
    IQ HDL CHOLESTEROL
    CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
    HDL CHOLESTEROL KIT
    HDL CHOLESTEROL PRECIPITATING PROCEDURE
    HDL CHOLESTEROL PRECIPITATING REAGENT
    MULTICHEM HDL PRECIPITATING REAGENT #S0914
    WORTHINGTON HDL PRECIPITATING REAGENT SET

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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