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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: LTT FDA class 2

    Panels, Test, Susceptibility, Antimicrobial

    Microbiology

    View full classification →

    Antimicrobial Susceptibility Test Panels (product code LTT) are microbiology devices used to determine the susceptibility or resistance of bacterial isolates to a range of antimicrobial agents, guiding appropriate antibiotic therapy. Regulated under 21 CFR 866.1640, they are classified as a Class 2 device requiring a 510(k) premarket notification to demonstrate substantial equivalence before marketing. The device is eligible for third-party review and falls under the Microbiology specialty. It is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    47 matches
    K Number
    Device Name
    MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
    MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
    MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
    MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
    MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
    MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
    MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
    MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
    MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
    MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
    MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
    MICROSCAN MICROSTEP
    MICROSCAN MICROSTREP PLUS, MODEL B1027-201
    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
    MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
    MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
    MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
    MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
    PASCO MIC AND MIC/ID PANELS
    SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
    MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
    DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
    HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
    HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
    DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
    DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
    PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
    PASCO MIC AND MIC/ID PANELS
    DRIED GRAM-POSITIVE MIC/COMBO PANELS
    PASCO MIC AND MIC/ID PANELS
    DRIED GRAM-POSITIVE MIC/COMBO PANELS
    SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
    SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
    PASCO MIC AND MIC/ID PANELS
    DRIED GRAM-POSITIVE MIC/COMBO PANELS
    DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
    SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
    DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    DRIED GRAM-POSITIVE MIC/COMBO PANELS
    DRIED GRAM-NEGATIVE CEFPODOXIME

    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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