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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: CGR FDA class 2

    Radioimmunoassay, Cortisol

    Clinical Chemistry

    View full classification →

    The Radioimmunoassay, Cortisol test system (product code CGR) is an in-vitro diagnostic device used in clinical chemistry to measure cortisol levels in serum, plasma, or urine using a radioimmunoassay method, aiding in the diagnosis of adrenal disorders such as Cushing's syndrome and Addison's disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1205 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Access Cortisol; DxC 500i Clinical Analyzer
    Access Cortisol
    IDS Cortisol
    IMMULITE/IMMULITE® 1000 Cortisol
    IMMULITE® 2000 Cortisol
    CORTISOL ELISA
    VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
    IBL CORTISOL LIA TEST KIT
    CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
    NICHOLS ADVANTAGE CORTISOL
    CORTISOL LIA
    NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
    VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY
    NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
    ACCESS CORTISOL ASSAY (MODIFICATION)
    CIBA CORNING ACS CORTISOL IMMUNOASSAY
    ACE CEDIA CORTISOL ASSAY
    ACCESS CORTISOL REAGENTS
    SYNELISA CORTISOL
    IMMULITE CORTISOL
    CORTISOL CHEMILUMINESCENCE ASSAY
    SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
    UBI MAGIWEL CORTISOL QUANTITATIVE
    SEROZYME CORTISOL TEST KIT
    ENZYMUN TEST(R) CORTISOL
    CEDIA (TM) CORTISOL ASSAY
    MODIFIED CEDIA(TM) CORTISOL ASSAY
    MILENIA(TM) CORTISOL (MKCO1,5)
    CORTISOL CLASP-BEAD EIA KIT
    DSL 7800 ACTIVE CORTISOL
    CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
    CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
    TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
    PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
    RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
    CORTISOL SYSTEM BY EIA
    ACTIVE CORTISOL DSL 2000-SP
    SOPHEIA/MP CORTISOL EIA KIT
    LEECO CORTISOL-QUANT
    STRATUS CORTISOL FLUOROMETRIC ENZYME
    CORITSOL PREMIX RIA KIT
    CORNING MAGIC CORTISOL RADIOIMMUNO
    CORTI-COTE CORTISOL SOLID PHASE RADIO
    AMER. BIO-SCIENCE LAB CORTISOL REAGENT
    IMMPULSE CORTISOL ASSAY REAGENTS
    NML CORTISOL RIA
    PHASE II CORTISOL KIT
    CORTISOL RADIOIMMUNOASSAY KIT
    EMIT SRD MANUAL CORTISOL ASSAY
    CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK

    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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