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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: LON FDA class 2

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    Microbiology

    View full classification →

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation is an automated microbiology system that rapidly determines the susceptibility or resistance of bacterial isolates to a panel of antimicrobial agents using abbreviated incubation periods, providing clinically actionable results more quickly than conventional methods to guide antibiotic therapy selection. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LON, regulated under 21 CFR 866.1645, within the Microbiology medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
    VITEK COMPACT PRO
    BD Phoenix™ Automated Microbiology System
    BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
    VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
    Colibrí
    VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
    VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
    VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
    Selux AST System; Model AST Gen 1.0
    VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
    VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
    VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
    VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
    VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
    Selux AST System; Model AST Gen 1.0
    VITEK 2 AST-Gram Positive Cefoxitin Screen
    Colibrí System
    VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
    VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
    VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
    VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
    VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
    VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
    VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
    VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
    VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
    VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
    VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
    VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
    LabPro Data Management System
    VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
    VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
    VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
    Vitek Densichek
    VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
    BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
    VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
    VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
    VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
    VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
    VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
    VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
    BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
    BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)
    BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
    VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
    VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
    VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
    BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

    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
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