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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: JJT FDA class 1

    Enzyme Controls (Assayed And Unassayed)

    Clinical Chemistry

    View full classification →

    This device consists of assayed and unassayed enzyme controls used in clinical chemistry laboratories to verify the accuracy and precision of enzyme activity measurements such as AST, ALT, LDH, and alkaline phosphatase across analytical systems and testing runs. It is classified as FDA Class 1, subject only to general controls with no premarket notification required. The product code is JJT, regulated under 21 CFR 862.1660, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
    MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
    CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
    ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
    CARDIASURE CARDIAC MARKERS CONTROL
    QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
    CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
    QUANTEX ASO-CRP-RP CONTROL II
    CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
    CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
    LIQUICHEK CARDIAC MARKERS CONTROL LT
    TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL
    DADE TRU-LIQUID CARDIAC CONTROL
    CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
    CARDIAC STATUS CONTROLS
    QUANTEX ASO-CRP-RF CONTROL
    CARDIOISOZYME, CK/LD ISOENZYME CONTROL
    STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
    STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
    STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
    LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
    OPUS CK-MB & TOTAL CK CONTROLS
    LIQUID CARDIAC MARKER 1,2,3 ASSAYED
    ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
    QUANTITATE ENZYME VERIFIER SET
    CARDIO REP LD CONTROL - CAT NO. 3325
    CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL
    CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
    CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
    CARDIOCHEX CKMB MASS MEASUREMENT CONTROL
    CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL
    CARDIOCHEX
    HICHEM ENZYME VERIFIER KIT
    CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
    ROCHE CARDIOTROL-CK
    CKMB CONTROL - LEVEL 1,2,3
    CKMB ISOENZYME CONTROL-LEVEL 1,2.3
    LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
    CK-MB IMMUNOASSAY CONTROL
    LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2
    HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
    CLP CK/LD ISOENZYME/IMMUNO CONTROL
    CLP CK/LD ISOENZYME CONTROL
    CK-MB/LD-1 CONTROL SYSTEM
    ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
    DADE(R) CK-MB IMMUNOASSAY CONTROL
    QUANTIMETRIX SERUM ENZYME CONTROL
    MULTI-ENZYME LINEARITY SOLUTION

    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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