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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: GJS FDA class 2

    Test, Time, Prothrombin

    Hematology

    View full classification →

    The Test, Time, Prothrombin (product code GJS) is a hematology coagulation assay system used to perform the prothrombin time (PT) test, which evaluates the extrinsic and common coagulation pathways, monitors warfarin anticoagulation therapy, and screens for clotting factor deficiencies. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7750 in the Hematology specialty (HE), this device carries no flags for third-party review, implantation, life support, or GMP exemption.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    microINR System
    Xprecia Prime Coagulation System
    i-STAT PTplus Cartridge with the i-STAT 1 System
    microINR System
    STA- NeoPTimal
    Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
    HemosIL ReadiPlasTin
    microINR System
    Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
    microINR System
    CoaguChek XS Plus System
    CoaguChek XS Pro System
    CoaguChek Vantus System
    Xprecia Stride Coagulation System, Xprecia System PT Controls
    HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
    HEMOSIL READIPLAS TIN
    INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
    INRATIO/INRATIO2 TEST STRIPS
    COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
    COAGUCHEK XS PRO SYSTEM
    COAGUCHEK XS PLUS PST SYSTEM
    HANDHELD BASE UNIT
    INRATIO 2 PT MONITORING SYSTEM
    HEMOSIL RECOMBIPLASTIN 2G
    COAGUCHEK XS PLUS SYSTEM
    COAGUCHEK XS SYSTEM
    COAGUCHEK XS SYSTEM
    HEMOSIL PT-FIBRINOGEN HS PLUS
    ACTICLOT, MODEL 824
    HEMOSIL RECOMBIPLASTIN
    PHOSPHOPLASTIN RL
    COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
    PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
    INRATIO SELF-TEST
    PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
    HARMONY INR MONITORING SYSTEM
    VITAL SCIENTIFIC PT WITH CALCIUM
    I-STAT PROTHROMBIN TIME TEST
    INRATIO
    DADE THROMBOPLASTIN C PLUS
    HEMOSIL RECOMBI PLASTIN
    PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
    RUBICON PROTHROMBIN TIME MONITORING SYSTEM
    THROMBOREL S
    PACIFIC HEMOSTASIS THROMBOPLASTIN D
    AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
    AVOCET ACUSURE SYSTEM
    PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
    CARESIDE PT
    HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT

    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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