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: JBQ FDA class 2

    Antithrombin Iii Quantitation

    Hematology

    View full classification →

    An antithrombin III quantitation test is a laboratory assay used to measure the concentration or activity of antithrombin III in plasma, a natural anticoagulant protein whose deficiency is associated with increased risk of venous thromboembolism. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JBQ, regulated under 21 CFR 864.7060, within the Hematology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    INNOVANCE Antithrombin
    INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
    HEMOSIL ANTITHROMBIN
    HEMOSIL LIQUID ANTITHROMBIN
    BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
    HEMOSIL LIQUID ANTITHROMBIN XL
    CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
    COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
    COAMATIC AT-400
    IL TEST LIQUID ANTITHROMBIN
    K-ASSAY AT-III
    IL TEST ANTITHROMBIN
    IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
    SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
    SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
    COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
    CHROM Z CHROMOGENIC ASSAYS
    AT-III CALIBRATOR
    BIOMERIEUX HEMOLAB AT III
    ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
    ANTITHROMBIN III CHROMOGENIC ASSAY
    COATEST(R) ANTITHROMBIN III, MODIFICATION
    ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
    COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY
    LIATEST(R) AT III TEST KIT
    COACUTE ANTITHROMBIN CHROMOGENIC ASSAY
    SPECTROLYSE ATIII KIT
    BECKMAN ANTITHROMBIN III REAGENT KIT
    ORTHOKROME* ANTITHROMBIN
    ACTICHROME ATIII KIT
    TURBOX ANTITHROMBIN III
    BERICHROM(R) ANTITHROMBIN III
    ENZYGNOST(R) TAT REAGENTS
    DADE ANTITHROMBIN III CHROMOGENIC ASSAY
    IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
    GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
    IL TEST ANTITHROMBIN III ACTIVITY
    DIACROM * ATIII
    RABBIT ANTI-HUMAN ANTITHROMBIN III
    IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
    PROTOTRO/PROTEOLYTIC ENZYME CONTROL
    COATEST ANTITHROMBIN
    ACA ANTITHROMBIN III PLASMINOGEN CALIB
    ACA ANTITHROMBIN III TEST PACK
    ANTITHROMBIN III SCREEN KIT
    HELENA AT-III QUIPLATE PROCEDURE
    PHADECODE XA INHIBITOR ASSAY
    DETERMINATION OF ANTITHROMBIN III, 885
    ASSAY, CHROMOGENIC ANTITHROMBIN III
    ANTITHROMBIN III ASSAY

    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