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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: JTN FDA class 2

    Susceptibility Test Discs, Antimicrobial

    Microbiology

    View full classification →

    Susceptibility Test Discs, Antimicrobial are filter paper discs impregnated with specific concentrations of antimicrobial agents, used in disk diffusion testing (such as the Kirby-Bauer method) to determine the susceptibility or resistance of bacterial isolates to antibiotics, guiding clinical treatment decisions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JTN, regulated under 21 CFR 866.1620, and falls within the Microbiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HardyDisk AST Gepotidacin 10µg (GEP10)
    Ceftobiprole BPR 5 µg Disc
    Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
    HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
    HardyDisk AST Cefiderocol 30µg (FDC30)
    Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
    Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
    HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
    BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
    HardyDisk AST Rezafungin 5µg (RZF5)
    BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
    Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
    Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
    Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
    Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
    HardyDisk AST Cefiderocol 30ug (FDC30)
    HardyDisk AST Lefamulin 20µg (LMU20)
    HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
    HardyDisk AST Omadacycline 30µg (OMC30)
    Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
    HardyDisk AST Eravacycline 20µg (ERV20)
    HardyDisk AST Plazomicin 30ug (PLZ30)
    HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
    HardyDisk AST Delafloxacin 5 µg (DLX5)
    HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
    HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
    HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
    BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
    CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
    HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
    TELAVANCIN 30 UG, BBL SENSI-DISC
    HARDYDISK AST TELAVANCIN,30UG
    FLUCONAZOLE 25UG BBL SENSI-DISC
    VORICONAZOLE 1UG BBL SENSI-DISC
    DORIPENEM 10UG BBL SENSI-DISC
    HARDYDISK AST DORIPENEM 10 UG
    ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
    TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    TIGECYCLINE 15UG BBL SENSI-DISC
    TELITHROMYCIN 15UG BBL SENSI-DISC
    GEMIFLOXACIN, 5UG BBL SENSI-DISC
    DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    ERTAPENEM 10UG BBL SENSI-DISC
    HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
    HARDKYDISK NEOMYCIN, 30 MCG
    HARDYDISK BACITRACIN, 10MCG, MODEL Z927
    LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    HARDYDISK SULFISOXAZOLE

    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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