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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: GQL FDA class 2

    Antisera, Fluorescent, Herpesvirus Hominis 1,2

    Microbiology

    View full classification →

    The Antisera, Fluorescent, Herpesvirus Hominis 1,2 is a fluorescent-labeled antiserum used in laboratory tests to identify herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in clinical specimens via immunofluorescence. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GQL, regulated under 21 CFR 866.3305 in the Microbiology specialty. No special flags apply to this device.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    ELVIS HSV ID AND D3 TYPING TEST SYSTEM
    LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
    THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
    THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
    INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
    HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
    PATHODX HERPES TYPING
    BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
    BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
    HSV-1 ELISA TEST SYSTEM
    HSV-2 ELISA TEST SYSTEM
    ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
    HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
    DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
    ORTHO DNA PROBE HSV CONFIRMATION TEST
    PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
    CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
    GIBCO HERPES ID KIT
    AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
    CULTURESET HSV ISOLATION & ID SYS
    MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
    SCOTT SELECTICULT-HSV ISOLATION &
    MICROTRAK HSV 1 & 2 CULTURE
    HERPES IDENT. & TYPING TEST HITT
    HSV IGM TEST
    INDIRECT FLUORO-KIT HSV
    HERPES SIMPLEX VIRUS TYPING REAGENTS
    MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
    FLUOROSET IMMUNOFLUORESCENT ANTIBODY
    IMMULOK CULTURESET
    HISTOSET IMMUNOPEROFIDASE TISSUE
    HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
    DIRECT FLUORESCENT ANTIBODY KIT/HERPES
    HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT
    FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
    HERPES I.D. TM TEST
    HSV 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.

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