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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: DCN FDA class 2

    System, Test, C-Reactive Protein

    Immunology

    View full classification →

    This is a test system for detecting and quantifying C-reactive protein (CRP) in clinical specimens, providing an immunoassay platform for measuring this widely used inflammatory marker in the evaluation of infection, autoimmune disease, and cardiovascular risk. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DCN, regulated under 21 CFR 866.5270, within the Immunology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CardioPhase® hsCRP
    RCRP Flex reagent cartridge
    Tina-quant C-Reactive Protein IV
    Optilite High Sensitivity C-Reactive Protein Kit
    Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
    MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
    C-Reactive Protein Kit for use on SPAPLUS
    HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
    PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
    C-REACTIVE PROTEIN (LATEX)
    PATHFAST HSCRP
    S-TEST C-REACTIVE PROTEIN (CRP)
    ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
    ROCHE-CREACTIVE PROTEIN (LATEX)
    I-CHROMA CRP TEST
    DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
    DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
    BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
    TINA-QUANT CRP (LATEX)
    C-REACTIVE PROTEIN (CRP)
    PAROS CRP
    CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
    SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
    CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
    CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
    WAMPOLE HS-CRP ELISA
    BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
    CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
    CRP HS TEST SYSTEM
    RCRP FLEX REAGENT CARTRIDGE
    WAKO CRP-UL, CRP-UL CALIBRATOR SET
    IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
    OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
    CRP
    REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
    RAPET CRP
    OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
    CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
    SPQ CRP CONTROL LEVEL II
    EYE SPOT CRP TEST
    SYNCHRON C-REACTIVE PROTEIN REAGENT
    RHEUMAJET CRP
    CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
    RAPITEX (R) CRP NEW
    RAICHEM(TM) SPIA(TM) CRP REAGENT
    QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
    V-TREND TARGET CRP TEST
    QM300 PCR ANTIBODY PACK
    DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
    WAKO(TM) CRP

    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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