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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: LCX FDA class 2

    Kit, Test, Pregnancy, Hcg, Over The Counter

    Clinical Chemistry

    View full classification →

    An over-the-counter pregnancy test kit using human chorionic gonadotropin (hCG) detection is a home-use diagnostic device that detects the presence of hCG in urine to indicate whether a woman is pregnant, providing a rapid, qualitative result without laboratory equipment. It is classified as FDA Class 2, reflecting moderate risk and the requirement for 510(k) premarket clearance. The product code is LCX, regulated under 21 CFR 862.1155, in the Clinical Chemistry specialty. Third-party review eligibility applies.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
    Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
    FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
    iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
    HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
    Shinetell Digital Pregnancy Test
    MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
    Distinct® Digital Pregnancy Test
    HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
    ACESO Early Pregnancy Test
    FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream
    Clearblue® Early Detection Pregnancy Test
    EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
    Macro & Micro-Test HCG Pregnancy Test Midstream
    MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
    MissLan™ Digital Pregnancy Rapid Test
    Clearblue ® Early Pregnancy Test
    hCG One Step Pregnancy Test
    Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
    One Step Pregnancy Test
    SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
    Clearblue® Early Digital Pregnancy Test
    Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
    Distinct® Early Detection Pregnancy Test
    hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
    CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
    INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
    HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
    VeriClear Digital Early Result Pregnancy Test
    WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
    DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
    Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
    Acro HCG Pregnancy Rapid Test
    David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
    Preview Digital Pregnancy Test
    ACRO HCG Pregnancy Rapid Test
    LIA Pregnancy Test
    Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
    One Step hCG Pregnancy Test
    Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
    ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
    UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
    FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
    FIRST RESPONSE EARLY RESULT PREGNANCY TEST
    CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
    HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
    FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
    EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
    QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
    FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

    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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