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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: LGC FDA class 2

    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

    Microbiology

    View full classification →

    An enzyme-linked immunosorbent assay (ELISA) for herpes simplex virus (HSV) in a non-type-specific format is a laboratory test that detects antibodies to herpes simplex virus without distinguishing between HSV-1 and HSV-2, used for serological screening and diagnosis of herpes infection. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LGC and is regulated under 21 CFR 866.3305 within the Microbiology specialty. No special flags apply to this device.

    510(k) Clearances

    38 matches
    K Number
    Device Name
    HERPES GROUP IGG
    MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
    DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
    HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
    THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
    POCKIT HSV 2 RAPID TEST
    PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
    HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
    HSV 1+2 IGG ELISA TEST
    DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
    HERPES GROUP IGG ELISA TEST SYSTEM
    SERAQUEST HSV IGG
    IMMULITE HERPES I AND II IGG
    PREMIER HSV PLUS
    ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
    BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
    BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
    HSV-2 IGM ELISA TEST--MODIFICATION
    HSV-1 IGM ELISA TEST -- MODIFICATION
    BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
    BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
    ORTHO HSV ANTIGEN ELISA TEST
    HSV-2 IGM ELISA TEST
    HSV-2 IGG ELISA TEST
    HSV-1 IGG ELISA TEST
    HSV-1 IGM ELISA TEST
    IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
    KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
    SEROCARD HSV IGG ANTIBODY TEST KIT
    HERPTRAN CONCENTRATE
    IDEIA HERPES SIMPLEX VIRUS TEST
    MODIFIED DDI SEROCARD HERPES IGG TEST KIT
    KODAK SURECELL HERPES (HSV) TEST KIT
    ELISA FOR HERPES SIMPLEX VIRUS
    ABBOTT HSV EIA
    HSV ANTIGEN ELISA KIT
    HERPELISA KIT
    TEST KIT FOR DETECTION OF HERPES SIMPLEX

    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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