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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: LRG FDA class 2

    Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

    Microbiology

    View full classification →

    This instrument is an automated reader and interpretation system used with overnight antimicrobial susceptibility testing panels, providing automated reading of results and interpretive reporting to guide antibiotic therapy decisions. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LRG, regulated under 21 CFR 866.1640, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    Thermo Scientific Sensititre ARIS HiQ System
    Thermo Scientific Sensititre ARIS HiQ System
    SENSITITRE OPTIREAD
    AUTOREADER 2
    MICROSCAN(R) MICROSTREP PLUS(R)
    MICROSCAN (R) MICROSTREP PLUS (R) PANELS
    MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
    MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
    MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
    MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
    MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
    MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
    MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
    MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)
    MICROSCAN MICROSTREP PLUS PANEL
    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
    MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
    MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
    MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
    MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
    ALAMAR ANTIBIOTIC SUSCEPTIBILITY
    READAR
    SYNERGY SCREEN TEST, MODIFICATION
    READAR
    READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
    MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
    SENSITITRE ARIS MODULE
    WALKAWAY TM 40
    AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
    AUTOSCEPTOR
    SCEPTORPETTE SYSTEM
    ALADIN (TM)

    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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