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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: JIL FDA class 2

    Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

    Clinical Chemistry

    View full classification →

    Enzymatic Method for Glucose (Urinary, Non-Quantitative) is a clinical chemistry test system using enzymatic reactions to detect the presence of glucose in urine on a non-quantitative basis, used for screening of diabetes mellitus and renal glycosuria. 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 JIL, regulated under 21 CFR 862.1340, 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
    AUTION MAX AX-4060 Urinalysis System
    cobas u 601 urinalysis test system
    DIP/U.S. Urine Analysis Test System
    inui In-Home Urine Analysis Test System
    DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
    DUS R-50S (Urine Chemistry system)
    iChemVELOCITY Automated Urine Chemistry System
    AUTION ELEVEN Semi-Automated Urinalysis System
    URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
    TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
    URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
    FORESIGHT U120 URINE ANALYZER
    URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
    CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
    COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
    COMBI SCAN100
    URINE CHEMISTRY ANALYZER UR-50
    CLINITEK ADVANTUS, MODEL 1420
    URYXXON RELAX URINE ANALYZER
    ICHEM 100 URINE CHEMISTRY ANALYZER
    CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
    URYXXON 200 URINE ANALYZER
    URISCAN OPTIMA II URINE ANALYZER
    CHEMVIEW-10
    DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
    COMBI-SCREEN, MODELS 10SL AND 11SL
    CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
    POCKETCHEM UA AUTION STICKS 10TA
    URS-IG (GLUCOSE TEST)
    URISYS 2400 URINE TEST STRIP
    DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
    MEDI-TEST COMBI 11
    DBEST REAGENT STRIP FOR URINALYSIS
    CLINISTRIP
    HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
    DIA SCREEN 10 WAY REAGENT STRIPS
    FIRST CHOICE GLUCOSE URINE TEST STRIPS
    BIOSCAN
    DIA SCREEN REAGENT STRIPS
    IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
    URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD
    URINE REAGENT STRIP-3 PARAMETERS
    BIOSCAN REAGENT STRIPS
    UROPAPER EIKEN 6B
    UROPAPER EIKEN HAG
    UROPAPER EIKEN AG
    UROPAPER EIKEN GP
    UROPAPER
    UROPAPER EIKEN 7
    UROPAPER EIKEN 8

    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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