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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: DCK FDA class 2

    C-Reactive Protein, Antigen, Antiserum, And Control

    Immunology

    View full classification →

    This is an immunological reagent kit for detecting and quantifying C-reactive protein (CRP), an acute-phase reactant protein synthesized by the liver in response to inflammation that is widely used as a clinical marker of infection, inflammatory disease, and cardiovascular risk. The kit includes antigen, antiserum, and control components for immunoassay testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DCK, regulated under 21 CFR 866.5270, within the Immunology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    K-ASSAY CRP (Ver.2)
    Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
    Yumizen C1200 CRP
    CRP Vario
    Yumizen C1200 CRP
    VITROS Chemistry Products hsCRP Reagent
    QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
    VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
    FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
    DIAZYME HSCRP POC TEST KIT
    DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
    ABX PENTRA 400 : CRP
    CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
    NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
    CRP DIAGNOSTIC ASSAY
    WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
    QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
    N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
    CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
    QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
    ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
    EXTENDED RANGE HS CRP KIT, CAT NO:9200
    WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
    CRP-LATEX (II)X2 SEIKEN ASSAY KIT
    VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
    K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
    HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
    ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
    K-ASSAY HS-CRP CONTROLS
    RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
    RDI HS CRP KIT
    NYCOCARD CRP
    NYCOCARD CRP CONTROL
    BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
    SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
    K-ASSAY HS-CRP CONTROLS
    IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
    K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
    C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
    C-REACTIVE PROTEIN ANTISERUM KIT
    RANDOX C-REACTIVE PROTEIN
    DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
    K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
    K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
    K-ASSAY CRP
    K-ASSAY CRP CALIBRATOR SET
    ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
    IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
    IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
    C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100

    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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