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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: JJW FDA class 1

    Urinalysis Controls (Assayed And Unassayed)

    Clinical Chemistry

    View full classification →

    This device consists of assayed and unassayed urinalysis controls used in clinical laboratories to monitor the performance and reliability of urinalysis test systems that measure parameters such as glucose, protein, ketones, blood, pH, and specific gravity in urine specimens. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket submission. The product code is JJW, regulated under 21 CFR 862.1660, and assigned to the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    UA-Cellular Complete
    AUTION CHECK PLUS
    UA-CELLULAR COMPLETE
    RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
    MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
    CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
    IRISPEC,CA/CB/CC
    LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
    ADVIA CHEMISTRY MICROALBUMIN CONTROLS
    RANDOX URINE CONTROLS
    QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
    URICHEMTRAK LIQUID ASSAYED URINE CONTROL
    LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
    MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
    J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
    MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
    URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
    URINE CHEMISTRY CONTROL, LEVEL 2
    URINE CHEMISTRY CONTROL, LEVEL 1
    OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
    URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
    MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
    QUANTIFY(901)
    KENLOR LIQUID TOTAL URINE CONTROL
    IRISPEC URINE CHEMISTRY CONTROL PART A AND B
    NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
    KOVA LIQUA-TROL
    MAS LIQUID URINALYSIS CONTROL
    U-TROL LIQUID URINE DIPSTICK CONTROL
    CHEK-STIX CONTROL STRIPS FOR URINALYSIS
    SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
    BIOTROL CHEMISTRY URINE CONTROL
    KENLOR LIQUID URINE CONTROL
    MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
    LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
    LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
    LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
    QUANTIMETRIX URINE DIPSTICK CONTROL
    TESTPACK ACUTE HCG URINGE CONTROLS
    V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
    CANTROL URINE DIPSTICK CONTROL TWO LEVELS
    UROL-GUANT
    KOVA TROL I,II, III HUMAN URINE-DRIED
    OXALATE URINE CONTROLS NORMAL & ELEVAT
    BIOSURE
    LIQUI-URA CHEMISTRY URINE CONTROLS
    IRI SPEC URINALYSIS CONTROL
    URINE TOTAL PROTEIN CONTROL
    BIOCHECK POSITIVE URINE CONTROL
    NEGATIVE URINE CONTROL

    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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