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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: DHA FDA class 2

    System, Test, Human Chorionic Gonadotropin

    Clinical Chemistry

    View full classification →

    The Human Chorionic Gonadotropin (hCG) Test System is a diagnostic assay used to detect and measure human chorionic gonadotropin, a hormone produced during pregnancy and by certain tumors, in blood or urine samples. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification, and is regulated under 21 CFR 862.1155 within the Clinical Chemistry specialty. The device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
    iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
    Alinity i Total ß-hCG Reagent Kit, GLP systems Track
    Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
    Access Total ßhCG (5th IS)
    Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
    Elecsys HCG STAT
    ADVIA Centaur® Total hCG assay
    MAGLUMI 2000 HCG/ß-HCG
    Atellica IM Total hCG (ThCG)
    Alinity i Total ß-hCG Reagent Kit, Alinity i System
    Diazyme DZ-Lite Total beta-hCG Test System
    i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
    ACCESS TOTAL BHCG (5TH IS)
    LIAISON XL HCG
    ONE STEP HCG URINE/SERUM TEST
    OLYMPUS TOTAL BHCG TEST SYSTEN
    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
    DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
    STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
    NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
    IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
    CARESTART HCG ONE-STEP PREGNANCY TEST
    AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
    AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
    AIMSTEP PREGNANCY
    VICTORCH MEDITEK'S HCG TEST CARD
    STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
    ELECSYS HCG AND BETA TEST SYSTEM
    ELECSYS HCG TEST SYSTEM
    ABSOLUTE HCG PREGNANCY TEST
    IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
    DRX QT. HCG
    INSURE PREGNANCY TEST
    IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
    ABBOTT ARCHEITECT TOTAL B-HCG
    AIMSTICK PBD COMBO PREGNANCY
    AIMSTICK PBD PREGNANCY
    BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
    MIDSTREAM HOME REGNANCY TEST
    VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
    HUMAN CHORIONIC GONADOTROPIN METHOD
    BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
    ELECSYS HCG ASSAY
    HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD
    ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
    AMERLITE HCG-60 ASSAY
    AURAFLEX HCG
    BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
    SEALITE SCIENCES INC.

    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

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