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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: CEK FDA class 2

    Biuret (Colorimetric), Total Protein

    Clinical Chemistry

    View full classification →

    The Biuret Colorimetric Total Protein Test is a clinical chemistry device that measures total protein content in serum or plasma using the Biuret reaction, in which protein reacts with copper ions in alkaline solution to produce a purple-colored complex proportional to protein concentration, used in nutritional assessment and diagnosis of protein-related disorders. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CEK, regulated under 21 CFR 862.1635, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HICHEM TOTAL PROTEIN REAGENT
    TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
    CARESIDE TOTAL PROTEIN
    TOTAL PROTEIN OR TP
    CSF/URINE TOTAL PROTEIN
    STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
    TOTAL PROTEIN REAGENT
    DUPONT DIMENSION TOTAL PROTEIN METHOD
    TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
    TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
    TOTAL PROTEIN QVET
    SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
    DMA MICROPROTEIN PROCEDURE
    URINARY/CEREBROSPINAL FLUID PROTEIN
    TOTAL PROTEIN TEST (TPRO)
    MICROPROTEIN REAGENT SET
    OLYUMPUS TOTAL PROTEIN REAGENT
    SYNCHRON TOTAL PROTEIN TEST --MODIFIED
    SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
    NOVA TOTAL PROTEIN MODULE
    OLYMPUS TOTAL PROTEIN REAGENT
    WAKO AUTOKIT MICRO TP
    MICROPROTEIN-PR
    BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
    URINE/CSF MICROPROTEIN REAGENT
    TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
    ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
    TOTAL PROTEIN REAGENT SET
    SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
    QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM
    SYNERMED TOTAL PROTEIN REAGENT KIT
    BIURET (COLORMETRIC), TOTAL PROTEIN
    PROTEIN TEST FOR URINE AND CSF
    COULTER TOTAL PROTEIN REAGENT
    COBAS READY TOTAL PROTEIN REAGENT
    CLINISTAT TOTAL PROTEIN REAGENT TEST
    EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
    COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
    DMA MICROPROTEIN PROCEDURE
    TOTAL PROTEIN REAGENT
    TOTAL PROTEIN REAGENT
    TOTAL PROTEIN TEST (TP) ITEM #65670
    TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
    BIOTROL TOTAL PROTEIN H.P.
    TOTAL PROTEIN REAGENT SET
    WAKO(TM) AUTOKIT TOTAL PROTEIN
    TOTAL PROTEIN
    EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
    TOTAL PROTEIN REAGENT - BIURET METHOD

    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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