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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: GTY FDA class 1

    Antigens, All Groups, Streptococcus Spp.

    Microbiology

    View full classification →

    The Antigens, All Groups, Streptococcus Spp. is a collection of antigens representing all Lancefield serogroups of Streptococcus species, used in agglutination or precipitation tests for grouping streptococcal isolates in the clinical laboratory. It is an FDA Class 1 device requiring only general controls, with no premarket submission needed. Regulated under 21 CFR 866.3740 with product code GTY in the Microbiology specialty. No special flags apply to this device.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    Healgen Strep A Rapid Test Strip (Throat Swab)
    Sofia Strep A+ FIA, Sofia 2 Analyzer
    SOFIA (R) STREP A+ FIA
    WONDFO RAPID STREP A TEST
    SOFIA STREP A FIA
    BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
    CLEARVIEW ADVANCED STREP A , MODEL 737-430
    BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
    INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
    STATUS FIRST STREP A
    ACON STREP A RAPID TEST DEVICE
    ACON STREP A TWIST TEST DEVICE
    SAS STREPALERT
    SAS STREPALERT
    QUICKVUE DIPSTICK STREP A
    ACON STREP A RAPID TEST STRIP
    SAS STREP A TEST
    OSOM ULTRA STREP A TEST, MODEL 147
    STREP B OIA
    UNI-GOLD STREP A TEST KIT
    BIOSTREP A-DIRECT STREP A ANTIGEN TEST
    BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
    QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
    STREP B OIA
    QTEST(R) STREP
    BIOSTARS STREP A OIA -- MODIFICATION
    ABBOTT STREP A CONTROLS
    SLIDEX STREPTO-KIT
    KODAK SURECELL(TM) STREP A CONTROL FLUID SET
    ICON STREP B IMMUNOENZYMETRIC ASSAY
    STREPSLIDE
    ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
    RESPIRASTICK ENZYME IMMUNOASSAY TEST
    HYGEIA RAPID STREP A TEST
    DIRECTATEX STREP A
    STREPTOCOCCUS PNEUMONIAE CONTROL
    STREPTOCOCCUS GR. B CONTROL
    STREPTOCOCCUS GR. D
    PHADEBACT CSF POSITIVE CONTROLS
    PHADEBACT STREP POSITIVE CONTROLS
    MERITEC-STREP GROUP A BETA-HEMOLYTIC
    BBL DIRECTIGEN TEST KIT

    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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