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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: JFJ FDA class 2

    Catalytic Methods, Amylase

    Clinical Chemistry

    View full classification →

    Catalytic Methods for Amylase measurement are clinical chemistry test systems used to quantify amylase enzyme activity in serum or urine, supporting the diagnosis and monitoring of pancreatitis and other pancreatic or salivary gland disorders. They are classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification in addition to general and special controls. The product code is JFJ, regulated under 21 CFR 862.1070, within the Clinical Chemistry medical specialty. This device type is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Amylase2
    Atellica CH Amylase_2 (AMY_2)
    alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
    ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
    SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
    EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
    AMYLASE EPS REAGENT
    ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
    SENTINEL PANCREATIC AMYLASE
    AMYLASE LIQUID REAGENT, MODEL A532-200
    VITALAB AMYLASE REAGENT
    WIENER LAB AMILASA 405 AA LIQUIDA
    JAS AMYLASE LIQUID REAGENT
    SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
    WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
    GENZYME DIRECT-AMYLASE TEST REAGENT
    MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
    INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
    CARESIDE AMYLASE
    WAKO L-TYPE AMYLASE
    AMY
    AMY
    IL TEST AMYLASE
    AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
    ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
    PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
    AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    ACE AMYLASE REAGENT
    CATALOGUE NUMBER 321-07/15/50
    OLYMPUS AMYLASE REAGENT
    AMYLASE QVET
    DUPONT DIMENSION AMYLASE METHOD
    BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
    SYNERMED AMYLASE REAGENT KIT
    DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS
    AMYLASE
    INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
    AMYLASE REAGENT SET (KINETIC)
    GENZYME A-AMYLASE TEST REAGENT
    SILYL AMYL
    ETHYLIDENE AMYL
    LIQUID AMYLASE REAGENT SET
    OLYMPUS AMYLASE REAGENT
    MILES URINE AMYLASE METHOD
    AMYLASE TEST
    AMYLASE REAGENT
    ABBOTT QUICKSTART AMYLASE, #5AXX
    IL TEST(TM) AMLYLASE
    AMYLASE (COLORIMETRIC) REAGENT SET

    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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