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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: DHB FDA class 2

    System, Test, Radioallergosorbent (Rast) Immunological

    Immunology

    View full classification →

    The Radioallergosorbent (RAST) Immunological Test System is a laboratory assay used to identify and quantify allergen-specific IgE antibodies in patient serum, supporting the diagnosis and management of allergic conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5750 within the Immunology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
    ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
    Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
    Allergen-Specific IgE Assay 12 Allergen Bundle
    NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
    ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
    Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
    ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
    AP3600 Automated Instrument
    NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
    ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
    ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
    ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
    Phadia Prime
    ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut
    IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
    AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
    IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
    IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
    AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
    IMMUNOCAP ALLERGEN K82
    AP 72OS SEMI-AUTOMATED INSTRUMENT
    IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
    IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
    IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    IMMUNOCAP RAPID READER, MODEL 12-3600-10
    IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
    HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
    IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
    OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
    MODIFICATION TO: UNICAP SPECIFIC IGE
    CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
    IMMULITE 2000 ALLERGEN-SPECIFIC IGE
    IMMULITE 2000 SPECIFIC ALLERGENS
    IMMULITE 2000 MIXED ALLERGEN PANELS
    MYALLERGYTEST SYSTEM
    IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)

    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

    Commonly searched
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