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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: GKP FDA class 2

    Instrument, Coagulation, Automated

    Hematology

    View full classification →

    Instrument, Coagulation, Automated (product code GKP) is a fully automated analyzer used in hematology laboratories to perform a range of coagulation assays, including prothrombin time, activated partial thromboplastin time, fibrinogen determination, and other clotting studies, with automated sample handling and endpoint detection. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5400 in the Hematology specialty (HE), it is eligible for third-party review.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
    ACL TOP Family 70 Series
    ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
    ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
    ACL TOP 700 LAS
    ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
    ACL TOP
    ACL TOP MODEL, TOP
    SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
    FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
    MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
    COAG-A-MATE MAX
    TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
    SYSMEX CA-6000
    COAG-A-MATE MTX
    ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
    ACL 6000 SYSTEM (ACL 6000)
    STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
    THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
    PROTIME MICROCOAGULATION SYSTEM
    MICROSAMPLE COAGULATION ANALYZER
    ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
    STA AUTOMATED MULTI-PARAMETRIC ANALYZER
    HEMOLAB
    TAS ANALYZER
    ELECTRA 1600C AUTOMATIC COAGULATION TIMER
    CASCADE M, CAT. NO. 1710
    IL MCL-2 COAGULATION ANALYZER
    CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
    CASCADE 480
    CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
    ST-4 COAGULATION INSTRUMENT
    THROMBELASTOGRAPH
    CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
    KOAGULAB 60-S COAGULATION SYSTEM
    THROMBELASTOGRAPH(R)
    ELECTRA 1000C AUTOMATIC COAGULATION TIMER
    KOAGULAB* 32-S COAGULATION SYSTEM
    ELECTRA 900C AUTOMATIC COAGULATION TIMER
    COAG-A-MATE(R) XM
    COAG-A-MATE X2

    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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