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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: CIT FDA class 2

    Nadh Oxidation/Nad Reduction, Ast/Sgot

    Clinical Chemistry

    View full classification →

    The NADH Oxidation/NAD Reduction, AST/SGOT test system (product code CIT) is an in-vitro diagnostic device used in clinical chemistry to measure aspartate aminotransferase (AST/SGOT) activity in serum using a coupled enzymatic reaction monitored by NADH oxidation or NAD reduction spectrophotometrically. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1100 in the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
    ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
    ACTIVATED ASPARTATE AMINOTRANSFERASE
    AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
    COBAS C 111 ANALYZER
    HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
    WIENER LAB GOT (AST) UV AA LIQUIDA
    AST (SGOT)
    WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
    ATAC PAK AST REAGENT KIT
    VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
    WAKO L-TYPE GOT TEST
    BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
    SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
    AST/SGOT
    CARESIDE AST
    AST
    AST/SGOT LIQUID REAGENT - KINETIC METHOD
    AST
    ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
    ASPARTATE AMINOTRANSFERASE (AST)
    N-ASSAY L AST/GOT
    INFINITY AST REAGENT (PROCEDURE NO. 51)
    AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30
    AST OR SGOT
    AST/SGOT
    AST INCORPORATING DST
    ROCHE COBAS INTEGRA REAGENT CASSETTES
    ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
    ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
    HICHEM AST REAGENT KIT
    AST QVET
    LIQUID AST (SGOT)REAGENT SET
    KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
    ASPARTATE AMINOTRANSFERASE (AST) TEST
    STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
    OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
    ROCHE REAGENT FOR AST
    AST (GOT) - ASPARTATE AMINOTRANSFERASE
    IL TEST AST, PN 35312
    SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
    OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
    KING DIAGNOSTICS AST (GOT) REAGENT
    MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
    SYNERMED AST/GOT REAGENT KIT
    ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
    TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)
    ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
    COULTER DART AST (GOT) 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.

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