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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: JJS FDA class 1

    Controls For Blood-Gases, (Assayed And Unassayed)

    Clinical Chemistry

    View full classification →

    This device consists of assayed and unassayed controls for blood gas measurements, used in clinical laboratories to monitor the performance of blood gas analyzers measuring parameters such as pH, partial pressure of oxygen and carbon dioxide, and bicarbonate. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket submission. The product code is JJS, regulated under 21 CFR 862.1660, and assigned to the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CueSee Hypoxic
    Hematocrit and Metabolite QUALICHECK
    HIGH METABOLITE QUALICHECK
    RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
    MISSION CONTROLS
    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
    LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
    LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
    LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
    LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
    QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
    IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
    MULTICHECK
    QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
    TONOMETERED SLAINE BLOOD GAS CONTROL
    EUROTROL GAS - ISE CONTROL
    QUALICHECK 4 GLUCOSE
    STAT PROFILE ULTRA BLOOD GAS CONTROLS
    ALKO TONOMETERED SALINE CONTROL
    CERTAIN(R) ELITE LEVEL 1, 2 AND 3
    SPECTRUM CO-OXIMETER LINEARITY CONTROL
    MULTICHECK(TM)
    MICROBACT SOLID PLATE SYSTEMS
    BLOOD GAS/ISE LINEARITY CONTROL
    RNA MEDICAL'S EQUIL 55
    QUALICHECK 4
    QUALICHECK 3
    BLOOD GAS CONTROLS
    BLOOD GAS/CO-OXIMETRY CONTROL
    CO-OXIMETER CONTROLS
    QUALICHECK 2
    MULTI-FUNCTION BLOOD GAS CONTROL
    AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
    BAYER HEALTHCARE RAPIDQC PLUS
    MARQUEST QC-IV TONOMETER
    MULTI FUNCTION BLOOD GAS CONTROL
    BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
    AQUEOUS BLOOD GAS CONTROL
    AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
    CERTAIN HB CO-OXIMETER CONTROL
    REFEREE BLOOD GAS ANALYZER CONTROLS
    CORNING CERTAIN TM
    GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL
    FETAL-TEK CONTROL MATURE
    PATHWAY PH BLOOD GAS CONTROL
    SQC BUFFER

    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.

    Popular Product Codes

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