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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: JJY FDA class 1

    Multi-Analyte Controls, All Kinds (Assayed)

    Clinical Chemistry

    View full classification →

    This device consists of multi-analyte assayed controls used in clinical chemistry laboratories to simultaneously monitor the performance of analytical systems across multiple measurands in a single control run, enabling comprehensive quality assurance of laboratory test panels. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is JJY, regulated under 21 CFR 862.1660, and assigned to the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Multichem IA Plus
    Audit MicroControls Linearity FD Tumor Markers II
    Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
    VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
    Liquichek Cardiac Markers Plus Control LT
    VALIDATE Anemia Calibration Verification/ Linearity Test Kit
    Liquichek Maternal Serum II Control
    Audit MicroControls Linearity FD Tumor Markers II
    LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
    Audit MicroControls Linearity LQ Special Diabetes
    ABX PENTRA MICRO ALB CONTROL L/H
    LIQUICHEK TUMOR MARKER CONTROL
    RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
    LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
    LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
    LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
    RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
    LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
    LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
    RANDOX CSF CONTROLS LEVELS 2 AND 3
    MULTICHEM S PLUS / S PLUS (ASSAYED)
    MULTICHEM U
    V8 SP NORMAL CONTROL, ABNORMAL CONTROL
    MULTICHEM P
    MULTICHEM IA AND IA PLUS
    EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
    RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
    LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
    AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
    MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
    LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
    FASTPACK CONTROL KIT
    LIQUID ASSAYED MULTIQUAL PREMIUM
    LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
    LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
    RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
    LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
    LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
    RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
    THERMO SCIENTIFIC MAS OMNI-CARDIO
    CONE-TROL LIQUID CHEMISTRY CONTROLS
    LIQUICHEK URINE CHEMISTRY CONTROL
    EUROTROL GAS-ISE METABOLITES
    AUDIT MICROLQ SPINAL FLUID CONTROL
    AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
    AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
    RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
    RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
    IT/IF CONTROL
    THERMO SCIENTIFIC MAS OMNI-CORE

    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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