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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: JQW FDA class 1

    Station, Pipetting And Diluting, For Clinical Use

    Clinical Chemistry

    View full classification →

    The Station, Pipetting and Diluting, For Clinical Use is a clinical laboratory instrument used to accurately dispense, pipette, and dilute liquid specimens and reagents in defined volumes for use in clinical chemistry assays and other diagnostic testing procedures, improving throughput and reducing manual pipetting errors. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JQW and is regulated under 21 CFR 862.2750, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BD VIPER INSTRUMENT
    QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
    2700 SAMPLE MANAGER
    MASTERCAP AM 5.0/MASTERCAP RM 5.0
    MINI SAMPLER PROCESSOR
    GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
    MINI SAMPLE PROCESSOR
    MICROLAB 4000, MICROLAB 4200
    IMPACT
    GENESIS
    MEDTEC AUTOBLOT 2000
    ROBOCAP
    4 CHANNEL DISPENSER
    4 CHANNEL DISPENSER
    STAR I WORKSTATION
    BIOMEK SL WITH BIOMEK SL INCUBATOR
    STAT FAX 2600
    IMPACT
    SYSTEM WASHER 100
    AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM
    PLATO 3000
    MAXSOFTWARE
    ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE
    WELLWASH 4 MARK II
    DENLEY WELLPREP 2 SAMPLE PROCESSOR
    WELLPREP 2000 SAMPLE PROCESSOR
    AFFIRM PROCESSOR
    AUTOLOADER
    RSP MEGA SAMPLE PROCESSOR
    STACKING MICROPLATE WASHER
    HY-PREP SYSTEM
    WELLPREP 1
    ROSYS MODELS 100 AND 200
    ROBOTIC SAMPLE PROCESSOR
    MARK 5 ROBOTIC PIPETTOR
    STRATUS(R) AUTOMATED SAMPLE HANDLER
    ELECTRAPETTE (R)
    EPC ELECTRONIC PIPETTING SYSTEM
    MICROPLATE REAGENT DISPENSER
    KEMBLE LIQUID HANDLING SYSTEM DISPENSER
    EXEC-WASH SOLID PHASE WASHING SYSTEM
    NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
    ABBOTT COMMANDER PARALLEL PROCESSING CENTER
    SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
    DPC-ROBOSTAT(TM)
    DENLEY WELLDILL 3
    ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
    DENLEY WELLWASH 2 AND 4
    ROBOTIC SAMPLE PROCESSOR
    IMMUNO-WASH AUTOMATED TUBE WASHER

    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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