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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: DCF FDA class 2

    Albumin, Antigen, Antiserum, Control

    Immunology

    View full classification →

    This is an immunological reagent kit for detecting and quantifying albumin, the most abundant plasma protein responsible for maintaining oncotic pressure and transporting various molecules in the bloodstream, including antigen, antiserum, and control components for use in clinical immunology laboratories. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DCF, regulated under 21 CFR 866.5040, within the Immunology specialty.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    Optilite Low Level Albumin Kit
    Human Microalbumin kit for use on SPAPLUS
    Urine/CSF Albumin, Urine/CSF Albumin Calibrator
    HUMAN ALBUMIN CSF KIT
    TINA-QUANT ALBUMIN GEN.2
    EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
    TINA-QUANT ALBUMIN GEN 2
    COBAS 8000 MODULAR SERIES ANALYZER
    K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
    SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
    DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL
    NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
    DCL MICROALBUMIN ASSAY, MODEL 252-20
    VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
    DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
    N ANTISERUM TO HUMAN ALBUMIN
    IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
    COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
    LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM
    ALBUMIN TEST RID KIT
    TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
    MODIFIED QM300 ALBUMIN ANTIBODY PACK
    TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
    TECHNICON DPA-1(TM) SYSTEM
    QM300 ALBUMIN ANTIBODY PACK
    QM300 CALIBRATOR D PACK
    QM300 ALBUMIN ANTIBODY PACK
    MAT (TM) MICROALBUMIN TEST
    ALBUMIN IN SERUM
    ALBUMIN IN URINE
    MICROALBUMINURIA ASSAY
    RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI
    IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM
    ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE
    ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
    QUAN. COLOR. DETER. OF SERUM ALBUMIN
    LOW LEVEL HUMAN ALBUMIN TEST KITS

    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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