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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: CIX FDA class 2

    Bromcresol Green Dye-Binding, Albumin

    Clinical Chemistry

    View full classification →

    The Bromcresol Green Dye-Binding, Albumin test system (product code CIX) is an in-vitro diagnostic device used in clinical chemistry to measure albumin concentrations in serum using the bromcresol green (BCG) dye-binding colorimetric method, one of the most widely used techniques for serum albumin quantification. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1035 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Albumin BCG2
    Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
    VITROS XT Chemistry Products ALB-TP Slides
    ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
    ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
    ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
    POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
    ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
    EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
    EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
    S40 CLINICAL ANALYZER, S TEST ALB
    ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
    ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
    ATAC PAK ALBUMIN REAGENT
    VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
    PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
    WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
    CHEMWELL, MODEL 2900
    ALBUMIN
    ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
    ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
    RANDOX ALBUMIN
    ALBG
    ALBG
    CARESIDE ALBUMIN
    ALB OR ALBUMIN
    ALBUMIN
    TRACE COBAS MIRA RANGE
    DMA ALBUMIN PROCEDURE
    ALBUMIN QVET
    EMDS ALBUMIN (ALB) TEST
    OLYMPUS ALBUMIN REAGENT
    ALBUMIN TEST
    TRACE ALBUMIN-MR REAGENT
    OLYMPUS ALBUMIN REAGENT
    TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
    ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
    KODAK EKTACHEM DT SLIDES (ALB)
    SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
    SYNERMED ALBUMIN REAGENT KIT
    COULTER ALBUMIN REAGENT
    COBAS READY ALBUMIN REAGENT
    CLINISTAT ALBUMIN REAGENT TEST
    ALBUMIN TEST (ALB) ITEM NUMBER: 65401
    IQ ALBUMIN
    BIOTROL ALBUMIN
    ALBUMIN TEST (ALB) ITEM #65650
    A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
    ALBUMIN CAT. # 201-03

    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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