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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: JXA FDA class 1

    Kit, Screening, Urine

    Microbiology

    View full classification →

    Kit, Screening, Urine is a diagnostic microbiology kit designed to rapidly screen urine specimens for the presence of significant bacteriuria or urinary pathogens, helping to determine whether further culture and susceptibility testing is warranted. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JXA, regulated under 21 CFR 866.2660, and falls within the Microbiology medical specialty.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
    URISCREEN
    URINE SCREENING DEVICE
    TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
    MULTIPLE (IZON DBS & URINE COLLECTION KIT)
    MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
    MULTIPLE (IZON URINE COLLECTION KIT)
    CULTURIA MACCONKEY-MUG
    BAC-T-SCREEN
    DIASLIDE URINE CULTURING DEVICE
    URI-THREE(TM), MODIFICATION
    QUALTURE
    RAPIDEC UR
    GEN-PROBE PACE SYSTEM URINE SCREEN
    URISCREEN
    RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
    MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
    ROUND 1
    LYFO KWIK(TM) RUS KIT
    N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
    UTISCREEN(R) BACTERIAL ATP TEST
    RAPID BACTERIURIA SCREEN (RBS)
    SLIDE CULTURE U 'EIKEN'
    FILTRA-CHECK-UTI
    URICHECK
    BAC-T-SCREEN
    BACTERIURIA DETECT. DEVICE APTEK II
    BACTERIURIA DETECT DEVICE, MULTI SAMPLER
    ORTHO BACTERIURIA DETECTION SYS
    BACTERUERIA SCREENING PROCEDURE
    DIPCHEX DIP-SLIDE CULTURE SYS
    BAC-T-SCREEN BACTERIURIA DETECTION DEV
    RAPID BACTERIURIA SCREENING TEST
    LUMAC'S BACTERIURIA SCREENING KIT
    URI-DIP (R)
    CULTURIA MACCONKEY/CLED #DM87
    CULTURIA MACCONKEY/COLUMBIA CNA
    CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
    MS-2 AUTOMATED URINE SCREENING SYSTEM
    VAC-U-PAC KIDNEY CASSETTE
    TILL-U-TEST, DIP SLIDE
    URINE SCREENING KITS
    TILL-U=TEST
    MICROCULT-ID

    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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