BEUDAMED
    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: CHP FDA class 1

    Radioimmunoassay, Estradiol

    Clinical Chemistry

    View full classification →

    The Radioimmunoassay, Estradiol test system (product code CHP) is an in-vitro diagnostic device used in clinical chemistry to measure estradiol, the predominant form of estrogen, in serum or plasma using a radioimmunoassay technique, supporting evaluation of reproductive endocrinology and hormone-related conditions. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1260 in the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
    17 B-ESTRADIOL (ELISA)
    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
    ACS ESTADIOL-6 II
    VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
    ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
    ELECSYS ESTRADIOL ASSAY
    VIDAS ESTRADIOL II (E2II) ASSAY
    CIBA CORNING ACS ESTRADIOL-6 ASSAY
    ULTRA-SENSITIVE ESTRADIOL
    ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
    AURAFLEX(R) ESTRADIOL
    COAT-A-COUNT(R) ESTRADIOL-6
    CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
    IMMULITE ESTRADIOL
    CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
    AIA-PACK E2 ASSAY
    STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
    OPUS ESTRADIOL
    COTUBE ESTRADIOL RADIOIMMUNOASSAY
    VIDAS ESTRADIOL (E2) ASSAY
    IMX ESTRADIOL
    ENZYMUN-TEST ESTRADIOL
    MILENIA ESTRADIOL
    ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
    SR1 ESTRADIOL ENZYME IMMUNOASSAY
    STRATUS ESTRADIOL FLUOREMETRIC ENZYME
    MODIFIED DELFIA ESTRADIOL KIT
    ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
    AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
    ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
    AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
    TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
    DELFIA ESTRADIOL KIT
    DSL ACTIVE ESTRADIOL RIA (DSL #4300)
    DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
    DOUBLE ANTIBODY ESTRADIOL RIA KIT
    ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
    PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS
    125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
    ESTRADIOL DIRECT RIA KIT
    ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
    COAT-A-COUNT ESTRADIOL KIT
    LEECO E2 QUANT DIAG. TEST KIT
    ESTRADIOL KIT BY RIA
    ESTRIOL RADIOIMMUNOASSAY TEST KIT
    17B ESTRADIOL
    NORDICLAB ESTRADIOL RIA TEST
    ESTRADIOL KIT BY RIA
    ESTRADIOL RIA KIT

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump