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: CGI FDA class 1

    Radioimmunoassay, Estriol

    Clinical Chemistry

    View full classification →

    The Radioimmunoassay, Estriol test system (product code CGI) is an in-vitro diagnostic device used in clinical chemistry to measure estriol, an estrogen produced primarily during pregnancy, in serum or urine using a radioimmunoassay technique. 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 862.1265 in the Clinical Chemistry medical specialty.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
    ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
    ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
    COAT-A-COUNT FREE ESTRIOL
    AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT
    AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
    MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
    IMMPULSE FREE ESTRIOL ASSAY REAGENTS
    SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
    RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
    TDX TOTAL ESTRIOL
    AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
    ENDAB ESTRIOL UNCONJUGATED
    RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
    DSL 1900
    FREE & TOTAL ESTRIOL KIT
    MICROMEDIC ESTRIOL RIA KIT
    DSL 1400
    AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
    QUANTIMUNE ESTRIOL RIA
    COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
    QUANTIMUNE ESTRIOL RIA
    ESTRIOL KIT
    NATAL-TEC ESTRIOL
    AMERLEX ESTRIOL RIA KIT
    IMMUNOREACTIVE ESTRIOL RIA KIT
    QUANTIMUNE E3 RIA
    ESTRIOL-SQUIBB RIA KIT
    ARIA II 125- I-ESTRIOL SYSTEM
    ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
    TOTAL ESTRIOL RIA KIT
    NORDICLAB TOTAL ESTRIOL RIA TEST
    RSL'S ASSAY PROCEDURE QUANTITATION
    I ESTRIOL
    RIA KIT, GAMMADAB ESTRIOL
    RIA, QUANTIMUNE E3
    DIRECT ESTRIOL RIA KIT
    I-ESTRIOL TEST SET
    HUMAN FOLLICLE STIMULATING HORMONE
    RIANEN ESTRIOL RIA KIT
    UNCONJUGATED ESTRIOL RIA KIT
    RIA-120 AND ESTRIOL REAGENT SYSTEM

    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