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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: GTZ FDA class 1

    Antisera, All Groups, Streptococcus Spp.

    Microbiology

    View full classification →

    The Antisera, All Groups, Streptococcus Spp. is a set of antisera used in standard serological agglutination methods to identify and group Streptococcus species across all Lancefield antigenic groups, supporting clinical diagnosis and epidemiological surveillance. It is an FDA Class 1 device, the lowest risk category, subject to general controls only and requiring no premarket clearance. The product code is GTZ, regulated under 21 CFR 866.3740 in the Microbiology specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
    UNI-GOLD STREP A TEST KIT
    MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
    BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
    ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
    STREP A OIA MAX
    STREPTOLEX-STAT
    OSOM STREP A TEST
    EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
    CARDS Q.S. STREP A
    BINAX STREP A TEST
    ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
    QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
    DIRECTIGEN 1-2-3 GROUP A STREP TEST
    MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
    QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
    QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
    ABBOTT TEST PACK STREP A TEST
    PROLEX (STREPTOCCAL GROUPING LATEX KIT)
    REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
    QUICKVUE IN-LINE ONE-STEP STREP A TEST
    MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
    STREP A NEGATIVE CONTROL
    QUIKPAC STREP A TEST
    PRECISE STREP A
    TESTPACK PLUS STREP A
    BBL STREP GROUPING KIT
    STREP A OIA
    OIA STREP A
    GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
    ICON STREP B IMMUNOENZYMETRIC ASSAY
    STREPTEX ACID EXTRACTION KIT
    REDITEST STREP A TEST KIT
    PATHO DX STREP D
    TESTPACK PLUS STREP A
    QUIDEL GROUP B STREP TEST
    VENTRESIGN STREP A TEST
    CARDS O.S.(TM) STREP A
    ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
    IMMUNOCARD STREP A TEST
    ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
    LEECO VIS-DISK STREP-A (EIA)
    CLEARVIEW STREP A
    VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT
    BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
    GROUP A STREP, BETA-STREP
    QUIDEL GROUP A STREP TEST
    KODAK SURECELL STREP A TEST KIT
    V-TREND STREP A TEST
    TARGET STREP A

    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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