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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: CDD FDA class 2

    Radioassay, Vitamin B12

    Clinical Chemistry

    View full classification →

    The Vitamin B12 Radioassay is a clinical chemistry device that uses radioisotope-based competitive binding or immunoassay techniques to measure the concentration of vitamin B12 (cobalamin) in blood or serum, used in the diagnosis of nutritional deficiencies, pernicious anemia, and related conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDD, regulated under 21 CFR 862.1810, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ARCHITECT Active-B12 (Holotranscobalamin)
    Access Vitamin B12
    DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
    LIAISON Vitamin B12
    ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
    Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
    ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
    Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
    Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
    LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
    AXIS-SHIELD ACVTIVE-B12
    DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
    A/C ENZYMATIC VITAMIN B6 ASSAY
    ARCHITECT B12
    ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
    ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
    POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
    B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
    POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
    DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
    AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
    IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
    ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
    ABBOTT AXSYM B12
    MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
    HOLOTC RIA
    VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
    BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
    VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
    ELECSYS VITAMIN B12 ASSAY
    ELECSYS FOLATE
    IMMULITE VITAMIN B12 (LKVB1,LKVB5)
    AXSYM B12
    AIA-PACK B12 ASSAY
    BUHLMANN VITAMIN B6 REA
    ACCESS VITAMIN B12 ASSAY (MODIFICATION)
    OPUS B12
    CEDIA VITAMIN B12 (NO BOIL) ASSAY
    VISTA B12 ASSAY
    ACCESS VITAMIN B12 ASSAY
    RADIAS B12 ENZYME IMMUNOASSAY
    STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
    AFFINITY B12
    CIBA CORNING ACS T3 IMMUNOASSAY
    CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
    CEDIA (R) VITAMIN B12/FOLATE ASSAY
    CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
    SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
    MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
    PHASE II B-12/FOLATE 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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