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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: PMN FDA class 2

    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

    Microbiology

    View full classification →

    The Assayed External Control Material For Microbiology Nucleic Acid Amplification (NAT) Assays (product code PMN) is a Class 2 microbiology device consisting of assayed external quality control material used to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use, regulated under 866.3920. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    31 matches
    K Number
    Device Name
    FilmArray TF Control Panel M527
    MDx-Chex for BCP
    MDx-Chex for BCN
    MDx-Chex for BCY
    FilmArray GI Control Panel M238
    SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
    SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
    MDx-Chex for BC-GN
    MDx-Chex for BC-GP
    SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
    SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
    BioFire JI Control Panel M420
    NATtrol BD MAX Vaginal Panel External Controls
    MDx-Chex for BCID2
    BioFire RP2.1/RP2.1plus Control Panel M441
    FilmArray Global Fever Panel External Control Kit
    FilmArray BCID2 Control Panel M416
    Cepheid Xpert Respiratory Control Panel
    Cepheid Xpert SA Nasal Complete Control Panel
    Cepheid Xpert MRSA NxG Control Panel
    Cepheid Xpert CT/NG Control Panel
    FilmArray Pneumonia/Pneumoniaplus Control
    Cepheid Xpert C. difficile/Epi Control Panel
    Cepheid Xpert GBS LB Control Panel
    BD MAX CT/GC/TV 20-Day QC Panel
    BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
    FilmArray RP2/RP2plus Control Panel
    FilmArray Warrior Control Panel M290
    FilmArray RP EZ Control Panel M265
    Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
    Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

    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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