BEUDAMED
    Product Code: LTT FDA class 2 21 CFR 866.1640

    Panels, Test, Susceptibility, Antimicrobial

    Microbiology

    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.

    View on FDA
    510(k)s
    50
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    11
    Years Active
    31

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    Basic Information

    Product Code
    LTT
    Device Class
    FDA class 2
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 50 510(k) clearances via K numbers.

    K Number Device Name
    K243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
    K250036 MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
    K250084 MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
    K202343 MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
    K201423 MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
    K193536 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
    K193358 MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
    K183127 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
    K172337 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
    K172912 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
    K172255 MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
    K162740 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
    K150039 MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
    K131275 MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
    K123933 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
    K111394 MICROSCAN MICROSTEP
    K091949 MICROSCAN MICROSTREP PLUS, MODEL B1027-201
    K091264 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
    K083262 MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
    K062773 MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
    K062777 MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
    K033940 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
    K030620 PASCO MIC AND MIC/ID PANELS
    K024357 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
    K024353 SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
    K021184 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
    K021111 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
    K021078 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
    K020939 MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
    K020627 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
    K020626 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
    K020160 DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
    K013368 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
    K013195 HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
    K010418 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
    K010159 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
    K011116 PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
    K010508 PASCO MIC AND MIC/ID PANELS
    K003619 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K001721 PASCO MIC AND MIC/ID PANELS
    K993102 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K983306 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
    K983309 SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
    K973317 PASCO MIC AND MIC/ID PANELS
    K972799 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K962150 DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
    K960366 SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
    K935704 DRIED GRAM-NEGATIVE MIC//COMBO PANELS
    K945235 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K941030 DRIED GRAM-NEGATIVE CEFPODOXIME

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.