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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: CFT FDA class 1

    Radioimmunoassay, Prolactin (Lactogen)

    Clinical Chemistry

    View full classification →

    The Radioimmunoassay, Prolactin (Lactogen) test system (product code CFT) is an in-vitro diagnostic device used in clinical chemistry to measure prolactin (also known as lactogen) levels in serum or plasma via a radioimmunoassay technique. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. It falls under regulation 21 CFR 862.1625 in the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PROLACTIN (PRL) HORMONE MICROPLATE ELISA
    VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
    SEALITE SCIENCES, INC. AQUALITE PROLACTIN
    ELECSYS PROLACTIN ASSAY
    DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
    DSL ACTIVE PROLACTIN IRMA
    ACCESS PROLACTIN ASSAY (MODIFICATION)
    ABBOTT IMX PROLACTIN(MODIFICATION)
    ABBOTT AXSYM PROLACTIN(MODIFICATION)
    AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
    ENZYME-LINKED FLUORESCENT IMMUNOASSAY
    AXSYM PROLACTIN
    DUPONT ACA PLUS PROLACTIN (PROL) METHOD
    ACCESS PROLACTIN
    COBAS CORE PROLACTIN EIA
    VISTA PROLACTIN ASSAY
    IMMULITE PROLACTIN
    IMMUCHEM PRL-MW ELISA
    AMERLITE PROLACTIN-30 ASSAY
    ELISA TUBE PROLACTIN TEST KIT
    PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
    AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
    PROLACTIN IRMA IMMUNOMAG
    OPUS(R) PROLACTIN TEST SYSTEM
    CIBA CORNING ACS PROLACTIN IMMUNOASSAY
    ELEGANCE PROLACTIN ELISA
    LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
    AFFINITY PROLACTIN TEST SYSTEM
    PROLACTIN (LACTOGEN) TEST SYSTEM
    COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
    ENZYMUN TEST(R) PROLACTIN
    ABBOTT IMX PROLACTIN
    MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
    SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
    CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
    MILENIA(TM) PROLACTIN (MKPR1,5)
    IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
    AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
    PRL-QUANT
    PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
    LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY
    BINAX PROLACTIN IRMA DIAGNOSTIC KIT
    FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201
    MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT
    PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
    PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
    HPROLACTIN KIT
    BECKMAN EPSILON(TM) PROLACTIN TEST KIT
    UBI MAGIWEL(TM) PROLACTIN QUANTATIVE
    TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN

    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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