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: CKA FDA class 1

    Nadh Oxidation/Nad Reduction, Alt/Sgpt

    Clinical Chemistry

    View full classification →

    The NADH Oxidation/NAD Reduction, ALT/SGPT test system (product code CKA) is an in-vitro diagnostic device used in clinical chemistry to measure alanine aminotransferase (ALT/SGPT) activity in serum using a coupled enzymatic UV spectrophotometric method based on NADH oxidation or NAD reduction, the standard kinetic method used in modern clinical analyzers for liver function assessment. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1030 in the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
    ACE ALT REAGENT
    DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
    CARESIDE ALT
    ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    TRACE REAGENT LINE FOR THE COBAS MIRA
    ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
    ALT OR SGPT
    ALT/SGPT
    ALT INCORPORATING DST
    CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE
    ALANINE AMINOTRANSFERASE REAGENT SYSTEM
    PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
    HICHEM ALT REAGENT KIT
    ALT QVET
    STANBIO ALT/GPT (LUQUI-UV) TEST SET
    SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
    LIQUID ALT(SGPT) REAGENT SET
    ALANINE AMINOTRANSFERASE (ALT) TEST
    HEMOCARD HEMOGLOBIN E
    OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
    ALT (GPT) - ALANINE AMINOTRANSFERASE
    ROCHE REAGENT FOR ALT
    EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
    IL TEST ALT, PN 35311
    OLYMPUS ALANINE AMINOTRANSFERASE REAGENT
    KING DIAGNOSTICS ALT (GPT) REAGENT
    SYNERMED ALT/GPT REAGENT KIT
    MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
    ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
    ABBOTT QUICKSTART ALANINE AMINOTRANSFER
    COULTER DART ALT (GPT) REAGENT
    ALANINE AMINOTRANSFERASE TEST
    NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
    TECHNICON AXON SYSTEM REAGENT METHODS
    PARAMAX ALANINE AMINOTRANSFERASE REAGENT
    COULTER ALT (GPT) REAGENT
    COBAS READY STAT PROFILE REAGENT STRIP
    ALANINE AMINOTRANSFERASE (ALT)
    TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
    ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
    ALT REAGENT (PROCEDURE NUMBER 159)
    ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
    ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
    CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
    ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
    ALANINE AMINOTRANSFERASE
    SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
    ALTLTS ALANINE AMINO TRANSFERASE ALT
    MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE

    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