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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: CGX FDA class 2

    Alkaline Picrate, Colorimetry, Creatinine

    Clinical Chemistry

    View full classification →

    The Alkaline Picrate, Colorimetry, Creatinine test system (product code CGX) is an in-vitro diagnostic device used in clinical chemistry to measure creatinine in serum or urine using the Jaffe alkaline picrate colorimetric method, a long-established technique for kidney function assessment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1225 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 Creatinine_3 (Crea3)
    Nova Allegro UACR Assay, Nova Allegro Analyzer
    Creatinine2
    Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
    DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
    DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
    EASYRA CREATININE REAGENT
    ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
    CREATININE
    ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
    SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
    SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
    SYNCHRON SYSTEMS CREATININE REAGENT
    CREATININE
    SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
    SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
    GENCHEM CREATININE REAGENT
    CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
    ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
    APPRAISE URINE MICROALBUMIN COLLECTION KIT
    CREATININE
    VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT
    CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
    CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
    DUAL VIAL CREATININE REAGENT
    CREA
    CREATININE (CREA)
    RANDOX CREATININE
    SYNERMED CREATININE REAGENT KIT
    SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
    CREA OR CREATININE
    CR PERFECT
    SIGMA DIAGNOSTICS CREATININE REAGENT KIT
    CREATININE REAGENT
    STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
    ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
    CR PERFECT
    CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)
    CREATININE QVET
    CREATININE-PO REAGENT KIT
    ROCHE REAGENT FOR CREATININE
    KODAK EKTACHEM DT SLIDES (URCR)
    CREATININE-S ASSAY
    OLYMPUS CREATININE REAGENT
    SIGMA CRE REAGENT
    OLYMPUS CREATININE REAGENT
    SYSTEMATE CREATININE TEST ITEM NUMBER 65413
    SYNERMED SINGLE REAGENT CREATININE KIT
    CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
    OLYMPUS CREATININE REAGENT

    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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