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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: JHI FDA class 2

    Visual, Pregnancy Hcg, Prescription Use

    Clinical Chemistry

    View full classification →

    Visual Pregnancy HCG (Prescription Use) is a clinical chemistry test system that uses a visual, typically immunochromatographic method to detect human chorionic gonadotropin (HCG) in urine or serum, confirming pregnancy in a prescription-use clinical setting. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JHI, 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
    Innovita HCG Pregnancy Rapid Combo Test
    Alltest Pregnancy Rapid Combo Test Cassette
    Atellica IM Total hCG (ThCG)
    TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
    Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
    WUNDER PREGNANCY TEST
    FASTEP S10 HCG SERUM/URINE COMBO TEST
    SOFIA(R) HCG FIA
    CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
    FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
    HOME PREGNANCY TEST
    RAPIDVUE HCG TEST
    FASTPACK HCG IMMUNOASSAY
    BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
    BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
    DBEST HCG PANEL TEST KIT
    INNOVACON HCG UKTRA TEST DEVICE
    LIFESIGN DXPRESS, MODEL LSR2000
    ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
    WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
    IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
    OSOM HCG COMBO TEST
    ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
    ZAP HCG TEST, MODEL 8001
    CLINITEST HCG PREGNANCY TEST
    ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
    MAINLINE MAXIE HCG URINE PREGNANCY TEST
    CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
    EASYCUP
    POLY STAT SERUM/URINE HCG TEST
    BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
    GENZYME CONTRAST II HCG URINE/SERUM TEST
    ACCESS TOTAL BHCG
    SAS BLOOD/SERUM/URINE/URINE HCG
    POLY STAT HCG DIPSTICK TEST
    LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
    QUPID PLUS E.R.
    STATUS HCG SERUM/URINE
    QUICKVUE ONE-STEP HCG-URINE
    QUICKVUE ONE-STEP HCG-COMBO
    SAS VALUE HCG
    ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
    VICTORCH HCG TEST STRIP
    POLY STAT HCG TEST
    UNIMARK HCG COMBO PREGNANCY TEST
    WH ACCU TEST PREGNANCY TEST
    HCG STAT PAK ULTRA-FAST
    SUREVUE URINE HCG
    SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST 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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