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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: MSJ FDA class 1

    Apolipoproteins

    Clinical Chemistry

    View full classification →

    An Apolipoproteins test system is a laboratory in vitro diagnostic device used to measure the concentration of specific apolipoproteins in blood, which are protein components of lipoproteins important in lipid metabolism and cardiovascular risk assessment. It is classified as FDA Class 1 under general controls, with product code MSJ and regulation number 21 CFR 862.1475, reviewed by the Clinical Chemistry panel. GMP requirements apply and no premarket submission is required. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DIAZYME APOLIPOPROTEIN A-1 ASSAY
    DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
    APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
    DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
    8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
    SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
    IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
    APO A-1 CHEMILUMINESCENCE ASSAY
    NICHOLS APO B CHEMILUMINESCENCE ASSAY
    IL TEST APOLIPOPROTEIN A1
    IL TEST APOLIPOROTEIN B (APO B)
    BACTON(TM), AUTO-APO A-1 REAGENT
    BACTON(TM), AUTO-APO B REAGENT
    APOLIPOPROTEIN TEST SYSTEM
    REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
    REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
    ROCHE REAGENT FOR APOLIPOPROTEIN A-1
    ROCHE REAGENT FOR APOLIPOPROTEIN B
    ORTHO APO B ELISA TEST SYSTEM
    BACTON TM, BASIC TM, APO B REAGENT
    SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B
    QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
    QM300 APOLIPOPROTEIN B ANTIBODY PACK
    TECHNICON DPA-1 APOLIPOPROTEIN B
    APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
    MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
    HEART CHECK APOLIPOPROTEIN A-1
    HEART CHECK APOLIPOPROTEIN-B
    APOLIPOPROTEIN B
    APOLIPOPROTEIN A1
    MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
    RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
    SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
    SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
    APO B., IMMUNOTURBIDIMETRIC ASSAY
    APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
    IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
    IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
    ICS APOLIPOPROTEIN B REAGENT TEST KIT
    ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
    VENTREX APO B
    BIOGRAM APO A1/B
    ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
    ANTISERUM TO HUMAN APOLIPOPROTEIN B
    APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
    THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL
    APO B RIA KIT
    LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
    DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
    TAGO DIFFU-GEN-APOLIPOPROTEIN B-100

    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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