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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: CIG FDA class 2

    Diazo Colorimetry, Bilirubin

    Clinical Chemistry

    View full classification →

    The Diazo Colorimetry, Bilirubin test system (product code CIG) is an in-vitro diagnostic device used in clinical chemistry to measure bilirubin concentrations in serum or plasma using the diazo reaction (Jendrassik-Grof or similar method), supporting the evaluation of liver function and hemolytic conditions. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1110 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
    Atellica® CH Diazo Direct Bilirubin (D_DBil)
    Atellica® CH Diazo Total Bilirubin (D_TBil)
    Total Bilirubin2
    VITROS XT Chemistry Products TBIL-ALKP Slides
    ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
    Total Bilirubin
    COBAS C BILIRUBIN TOTAL GEN.3
    S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
    EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
    COBAS INTEGRA BILIRUBIN DIRECT GEN.2
    ARCHITECT TOTAL BILIRUBIN
    ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
    POLY-CHEM 90 TOTAL BILIRUBIN
    GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
    EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
    COBAS INTEGRA 400/800 BILIRUBIN TOTAL
    TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
    EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
    OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
    COBAS INTEGRA C 111
    COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
    STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
    DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
    DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
    ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P
    TOTAL BILIRUBIN
    DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
    MODIFICATION TO ABL800 FLEX
    SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
    TOTAL BILIRUBIN REAGENT SET
    VITALAB DIRECT BILIRUBIN REAGENT
    ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
    ATAC TOTAL BILIRUBIN REAGENT
    WIENER LAB. BILIRUBINA DIRECT AA
    BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
    WIENER LAB. BILIRRUBINA TOTAL AA
    TOTAL BILIRUBIN
    DIRECT BILIRUBIN
    DIRECT BILIRUBIN REAGENT
    TOTAL BILIRUBIN REAGENT
    TOTAL BILIRUBIN
    DIRECT BILIRUBIN
    BAYER ADVIA IMS SYSTEM
    CARESIDE DIRECT BILIRUBIN
    BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
    MODIFICATION TO ALCYON DIRECT BILIRUBIN
    SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
    TBIL
    UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
    DBIL

    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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