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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: JPA FDA class 2

    System, Multipurpose For In Vitro Coagulation Studies

    Hematology

    View full classification →

    The System, Multipurpose for In Vitro Coagulation Studies is a hematology laboratory instrument capable of performing multiple coagulation tests on patient plasma specimens, supporting the evaluation of coagulation factor deficiencies, monitoring anticoagulant therapy, and diagnosing bleeding or thrombotic disorders. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JPA and is regulated under 21 CFR 864.5425, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Automated Blood Coagulation Analyzer CN-Series (CN-6000)
    TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
    TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
    Citrated: K, KH, RTH, FFH
    ACL TOP 970 CL
    ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
    STA R Max 3, STA Compact Max 3
    ROTEM sigma Thromboelastometry System
    GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
    Hemochron Signature Elite
    QNext and DG-PT
    TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
    CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
    Automated Blood Coagulation Analyzer CS-2500
    Sysmex CS-5100
    TEG 6s Hemostasis System
    ACL AcuStar
    Sysmex CS-2100i
    Sysmex Automated Blood Coagulation Analyzer CS-5100
    Sysmex Automated Blood Coagulation Analyzer CS-5100
    Sysmex Automated Blood Coagulation Analyzer CS-2100i
    Sysmex Automated Blood Coagulation Analyzer CS-2100i
    Sysmex Automated Blood Coagulation Analyzer CS-5100
    STA R MAX
    CORA (Coagulation Resonance Analysis) System
    STA COMPACT MAX
    EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
    ROTEM DELTA THROMBOELASTOMETRY SYSTEM
    STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
    STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
    DESTINY MAX COAGULATION ANALYZER
    ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
    BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
    BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
    STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
    STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
    SMARTCHECK INR SYSTEM
    ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
    ACL ELITE; ACL ELITE PRO
    COAG-A-MATE MTX III
    HEMORAM/AGGRAM ANALYZER
    IMMEDIA PROTHROMBIN TIME SYSTEM
    MDA B.30
    HEMOCHRON SIGNATURE ELITE
    HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
    POTENS +
    HEMOCHRON RESPONSE/SYSTEM
    MODIFICATION TO STANDARD HUMAN PLASMA
    AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
    HEMOCHRON JR. SIGNATURE +

    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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