BEUDAMED
    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: JIX FDA class 2

    Calibrator, Multi-Analyte Mixture

    Clinical Chemistry

    View full classification →

    This device is a multi-analyte mixture calibrator used in clinical chemistry systems to simultaneously calibrate an analyzer across multiple measurands in a single calibration run, improving workflow efficiency in high-throughput laboratory settings. It is classified as FDA Class 2, meaning it requires 510(k) premarket notification to establish substantial equivalence before commercial distribution. The product code is JIX, regulated under 21 CFR 862.1150, and belongs to the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VITROS Chemistry Products Calibrator Kit 3
    ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
    ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
    Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
    SYSTEM CALIBRATER
    C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
    ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
    DIMENSION CHEMISTRY III CALIBRATORY
    ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
    RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
    MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
    ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
    ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
    SYNCHRON MULTI CALIBRATOR
    ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
    ELECSYS ANTI-TPO CALSET
    MULTICONSTITUENT CALIBRATOR
    DIMENSION VISA ENZ 2 CAL
    ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
    LOCI 8 CALIBRATOR, MODEL KC 646
    DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
    ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
    EXL ANEM CAL, MODEL RC640
    STA - FREE PS CALIBRATOR
    CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
    EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
    DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
    SENTINEL PLASMAPROTEINS CAL 3X
    LOCI THYROID CALIBRATOR WITH MODEL RC610
    URIC ACID (AOX), SCAL, NORTROL, ABTROL
    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
    ABX PENTRA URINE CAL
    DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
    ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
    VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
    MODIFICATION TO SENTINEL CLIN CHEM CAL
    MULTI-ANALYTE CHEMISTRY CALIBRATOR
    DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
    DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL
    DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
    DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
    DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
    DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
    DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
    DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
    DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
    DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
    RANDOX LIQUID PROTEIN CALIBRATOR
    DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

    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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump