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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: JHJ FDA class 2

    Agglutination Method, Human Chorionic Gonadotropin

    Clinical Chemistry

    View full classification →

    Agglutination Method for Human Chorionic Gonadotropin is a clinical chemistry test system that detects HCG in urine or serum through agglutination inhibition reactions, used in the diagnosis of pregnancy and monitoring of conditions such as gestational trophoblastic disease. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JHJ, regulated under 21 CFR 862.1155, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PREGNACOL PREGNANCY TEST
    IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
    SAS(TM) DIRECT MONOCLONAL HCG
    ACCUTEX BETA-HCG TEST
    SAS(TM) MONOCLONAL HCG-SLIDE
    DIRECT PREGNANCY TEST
    CLEARVIEW HCG
    PREGNOSPIA II
    PREGNANCY (HCG) CARD & LIQUID TEST
    PREGNANCY BETA-HCG CARD & LIQUID TEST
    HCG-NOSTICK
    V-TREND BETA-HCG DRY-SPOT TEST
    V-TREND BETA-HCG TEST
    ACU-PREG-AL SLIDE TEST
    IMMUNO-CEPT D (BETA-MONOCLONAL)
    MONO ACU-SLIDE TEST
    PREGNASLIDE
    LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
    DELFIA (TM) HCG KIT
    DIRECT ACU-SLIDE TEST
    HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
    DIRECTACLONE CG SLIDE PREGNANCY TEST
    TERUMO SENSIBEAD EIG HCG KIT
    ACU-SLIDE-TEST
    DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
    PREGNANCY CARD TEST
    PRECO PREGNANCY RAPID CARD TEST, HEM #2028
    FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
    ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
    FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
    STANBIO QUICK-TELL MONOCLONAL INDIRECT
    DUOCLON COLOR-CEPT
    BETA-HCG HEMAGGLUTINATION TEST
    SLIDE PREGNANCY TEST
    PREG-BETA ONE HOUR TUBE TEST
    PREG BETA BLUS SLIDE
    PLUS URINE HCG ASSAY
    B-NEOCEPT 30
    BHCG-CHECK
    FERTITUBE PREGNANCY TEST #1120
    ORTHO B-HCG SLIDE TEST FOR PREGNANCY
    PREGNASTICK URINE HCG KIT
    QUIDEL HCG ENZYME IMMUNOASSAY KIT
    PREGNA-TEC
    B-SLIDE PREGNATE PREGNANCY TEST KIT
    QUICK-TELL INDIRECT PREGNANCY TEST
    EARLY IN HOME PREGNANCY TEST
    PREGNA-TEC
    FERTITELL DIRECT PREGNANCY TEST #1100
    GAMMA SLIDE TEST FOR PREGNANCY

    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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