BEUDAMED
    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: DFC FDA class 2

    Lipoprotein, Low-Density, Antigen, Antiserum, Control

    Immunology

    View full classification →

    This is an immunological reagent kit for detecting low-density lipoprotein (LDL), the primary carrier of cholesterol in the bloodstream and a major risk factor for atherosclerosis when elevated, including antigen, antiserum, and control components for clinical laboratory immunoassay testing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DFC, regulated under 21 CFR 866.5600, within the Immunology specialty.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    Tina-quant Lipoprotein(a) Gen.2 Molarity
    Lp(a) Ultra
    Diazyme Lipoprotein (a) Assay
    ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
    COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
    DIAZYME LP(A) ASSAY
    LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
    QUANTIA LA(A)
    K-ASSAY LP(A) CONTROLS
    K-ASSAY LP(A) ASSAY
    LP(A)-LATEX SEIKEN ASSAY KIT
    N LATEX LP(A)
    TINA-QUANT APOLIPOPROTEIN B VER.2
    TINA-QUANT APOLIPOPROTEIN B VER.2
    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
    WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
    WAKO AUTOKIT LP(A)/ RA,500/1000,
    WAKO AUTOKIT LP(A)/DADE DEMENSION
    WAKO AUTOKIT LP(A)/EXPRESS 550
    IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
    MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
    LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
    MACRA LP(A) ENZYME IMMUNOASSAY KIT
    LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
    INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
    SPQ TEST SYSTEM
    WAKO AUTOKIT LP(A)
    APOB
    IMX HOMOCYSTEINE
    APO-TEK LP(A)
    WAKO AUTOKIT APO B
    IL TEST CALIBRATION SET APO A1B
    UC IMU B
    EQUATE(TM) AQR APO AL/B DUO CONTROL
    QM300 CONTROL F PACK
    QM300 CALIBRATOR F PACK
    RAICHEM(TM) SPIA(TM) APO B REAGENTS
    ANTI-HUMAN LDL SERUM
    LAS-R BETA LIPOPROTEIN TEST
    LIPPOPROTEIN ELECTROPHORESIS REAGENT SET

    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
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump