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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: CEP FDA class 1

    Radioimmunoassay, Luteinizing Hormone

    Clinical Chemistry

    View full classification →

    The Luteinizing Hormone Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody techniques to measure luteinizing hormone (LH) levels in serum, used in the assessment of reproductive endocrine function, diagnosis of infertility, and evaluation of pituitary disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEP, regulated under 21 CFR 862.1485, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MAYBE?MOM MINI OVULATION MICROSCOPE
    INSTANT-VIEW LH OVULATION PREDICTING TEST
    AT HOME OVULATION TEST, MODEL 9032
    CLEARPLANE EASY OVULATION TEST
    TCI-31 LIFELONG OVULATION TESTER
    QUIK-CHECK OVULATION PREDICTOR
    SURE CHECK OVULATION PREDICTOR
    INVERNESS MEDICAL OVULATION PREDICTOR TEST
    EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
    EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
    OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
    BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
    CLEARPLAN EASY OVULATION TEST
    DBEST ONE-STEP OVULATION TEST
    TBD* ONE-STEP OVULATION PREDICTOR TEST
    EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
    VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
    ELECSYS LH ASSAY
    SEALITE SCIENCES, INC. AQUALITE LH
    OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
    OPUS HLH
    ACS LH2 IMMUNOASSAY
    MINICLINIC OVULATION PREDICTOR
    ACTIVE LH IRMA
    FIRST RESPONSE OVULATION PREDICTOR TEST
    CONCEIVE OVULATION PREDICTOR
    BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
    COAT-A-COUNT LH IRMA
    CHEMILUMINESCENCE LH
    PRO-STEP LH OVULATION PREDICTION TEST
    SEALITE SCIENCE, INC. AQUALITE(R) LH
    DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
    SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
    ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
    ONE STEP LH TEST
    COBAS CORE LH EIA
    VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
    OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
    IMMUCHEM LH-MW ELISA
    ELISA TUBE LH TEST KIT
    VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
    IMMULITE HLH
    LH GEN III SELF-TEST/CONCEIVE
    MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
    OPUS(R) LH TEST SYSTEM
    LH IRMA IMMUNOMAG
    MINICLINIC OVULATION PREDICTION TEST
    PANTEX IRMA LH 1251 KIT
    CIBA CORNING ACS LH IMMUNOASSAY
    BIOCLONES ELEGANCE LH ELISA 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.

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