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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: DGC FDA class 2

    Ige, Antigen, Antiserum, Control

    Immunology

    View full classification →

    The IgE Antigen, Antiserum, and Control is an immunological reagent used in clinical laboratories to detect and quantify IgE immunoglobulins, which are associated with allergic reactions, anaphylaxis, and parasitic infections. It is classified as FDA Class 2, requiring 510(k) premarket notification to establish substantial equivalence, and is regulated under 21 CFR 866.5510 within the Immunology specialty. The device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Kenota 1 Total IgE; Kenota 1 (instrument)
    Quantia IgE
    Total Immunoglobulin E (IgE)
    ADVIA Centaur Total IgE (tIgE)
    ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
    IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
    DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
    QUANTIA IGE
    K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
    LACRYTEST
    IMMUNETECH TOTAL IGE SYSTEM
    IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
    RANDOX IGE
    SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
    BIOCHECK IGE ELISA, MODEL BC-1035
    TOUCH TEAR IGE MICROASSAY KIT
    PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
    N LATEX IGE MONO REAGENT
    BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
    AIA-PACK IGE II ASSAY
    UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
    HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
    MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
    QUANTA LITE MITOCHONDRIA M2 ELISA
    COBAS(R) CORE IGE TOTAL EIA
    ACCESS(R) TOTAL IGE ASSAY
    PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION
    IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
    ACS TOTAL IGE IMMUNOASSAY
    KALLESTEAD TOTAL IGE MICROPLATE KIT
    BIOCLONE'S ELEGANCE IGE ELISA KIT
    PHARMACIA SPECIFIC IGE CONTROL
    POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
    VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
    QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
    LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY
    3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
    3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
    ABBOTT IMX IGE
    MILENIA(TM) TOTAL IGE (MKIE1,5)
    PROGENE IGE BEAD EIA
    PHARMACIA CAP SYSTEM IGE RIA AND FEIA
    ALATOP (TM) CATALOG # AKAL1
    N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
    FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
    DELFIA (TM) HIGE KIT
    PHARMACIA IGE RIA ULTRA
    PHARMACIA IGE EIA ULTRA
    PHARMACIA IGE RIACT
    RRT TOTAL IGE 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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