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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: LYR FDA class 1

    Helicobacter Pylori

    Microbiology

    View full classification →

    The Helicobacter Pylori detection device (product code LYR) is a microbiology diagnostic reagent used to identify Helicobacter pylori, a bacterium associated with peptic ulcers and gastric cancer, in patient specimens through serological or other detection methods. Regulated under 21 CFR 866.3110 and classified as a Class 1 device subject only to general controls, it falls under the Microbiology specialty and is eligible for third-party review. It is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hp Detect™ Stool Antigen ELISA
    Premier HpSA Flex (619096)
    Curian HpSA, Curian Analyzer
    Vstrip H. pylori Antigen Rapid Test
    PREMIER Platinum HpSA PLUS
    LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
    H. PYLORI CHEK™
    H. PYLORI QUIK CHEK
    LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
    ImmunoCard STAT! HpSA
    Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only
    VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
    HELICOBACTER PYLORI ELISA IGG TEST KIT
    GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
    RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
    PYLO-PLUS
    PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
    HELICOBACTER PYLORI IGG ELISA
    IMMUNOCARDSTAT HPSA
    PYLORI IGG
    INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
    ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
    QUANTA LITE H.PYLORI IGA ELISA
    NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
    PYLORITEK VP TEST KIT 5140VP
    OXOID PYLORI TEST KIT, MODEL DR0130M
    HP-ONE
    ELISA TEST, SEROLOGY
    PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
    MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
    VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
    MODIFICATION TO: PRONTO DRY
    IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
    UNI-GOLD H. PYLORI
    IS H. PYLORI IGG ELISA TEST SYSTEM
    HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
    QUICKVUE ONE-STEP H. PYLORI II TEST
    PRONTO DRY
    THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
    MODIFICATION TO: PREMIER PLATINUM HPSA
    ABBOTT TESTPACK PLUS H. PYLORI
    QUANTA LITE H. PYLORI IGG ELISA
    BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
    STAT-SIMPLE PYLORI
    HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
    PYLORIPROBE
    PREMIER PLATINUM HPSA
    SHIELD HELICO-G2 ELISA KIT
    PYLORI DETECT IGG
    ACCUSTAT H. PYLORI ONE STEP TEST

    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

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